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This is a pilot study in a randomized, controlled, double-blinded format and will evaluate the ability of a local anesthetic, Ropivacaine, to decrease pain after gastric bypass surgery. The drug will be administered into the abdomen during a bariatric bypass surgery. After surgery, patients who received Ropivacaine will be compared to those without Ropivacaine to determine its effect on reducing pain, recovery of lung function, ability to walk, and quality of life during recovery.
Introduction: Postoperative pain control remains a major challenge for surgical procedures, including laparoscopic gastric bypass. Pain management is particularly relevant in obese patients who experience a higher number of of cardiovascular and pulmonary events. effective pain management may reduce their risk of serious postoperative complications, such as deep venous thrombosis and pulmonary emboli. The objective of this study is to evaluate the efficacy of intraperitoneal local anaesthetic, ropivacaine, to reduce postoperative pain in patients undergoing laparoscopic Roux-en-Y gastric bypass.
Methods and Analysis: A randomized controlled trial will be conducted to compare intraperitoneal ropivacaine (Intervention) versus normal saline (placebo) in 120 adult patients undergoing bariatric surgery. Ropivacaine will be infused over the oesophageal hiatus and throughout the abdomen. Patients in the control arm will undergo the same treatment as normal saline. The primary end point will be postoperative pain at 1, 2 and 4 hours postoperatively. Pain measurements will then occur every 4 hours for 24 h and every 8h until discharge. Secondary endpoints will include opioid use, peak expiratory flow, 6 min walk distance and quality of life. Intention-to-treat analysis will be used and repeated measures will be analysed using mixed model approach. post-hoc pairwise comparison of the treatment groups at different time points will be carried out using multiple comparisons with adjustments to the type 1 error. Results of the study will inform the feasibility of effectiveness of intraperitoneal ropivacaine.
Ethics and dissemination This study has been approved by the Ottawa Health Science Network Research Ethics Board and Health Canada in April 2014. The findings of the study will be disseminated through national and international conferences and peer-reviewed journals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intraperitoneal Normal Saline | Placebo Comparator | Intraperitoneal Normal Saline: 100mL (Milliliter) normal saline administered as in intervention arm |
|
| Intraperitoneal ropivacaine | Experimental | The abdomen will be entered and trocars placed in the usual manner. Using a standard suction/irrigation device and tubing, 200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) will be instilled into the abdomen at the start of the case, prior to dissection as follows. Under direct visualization, 50mL (Milliliter) (of the 100mL) will be infused over the esophageal hiatus. The remaining 50mL will be infused throughout the abdomen. The infusion line will then be flushed with 30mL (Milliliter) of Normal Saline to ensure the entire treatment dose is delivered, and no Ropivacaine remains in the tubing. The remainder of the surgery will proceed as usual. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug |
|
| |
| Measure | Description | Time Frame |
|---|---|---|
| 0-1 h Postoperative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | 0-1 hours post operatively |
| 1-2 h Postoperative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | 1-2 hours post operatively |
| 2-4 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | 2-4 hours post operatively |
| 4-8 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | 4-8 hours post operatively |
| 8-12 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | 8-12 hours post operatively |
| 12-16 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | 12-16 hours post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 1h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | 1 hours post operatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Mamazza, MD | The Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Ottawa Hospital | Ottawa | Ontario | K1Y 4E9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34759045 | Derived | Jarrar A, Eipe N, Wu R, Neville A, Yelle JD, Mamazza J. Effect of intraperitoneal local anesthesia on enhanced recovery outcomes after bariatric surgery: a randomized controlled pilot study. Can J Surg. 2021 Nov 10;64(6):E603-E608. doi: 10.1503/cjs.017719. Print 2021 Nov-Dec. | |
| 25113556 | Derived | Wu R, Haggar F, Porte N, Eipe N, Raiche I, Neville A, Yelle JD, Ramsay T, Mamazza J. Assessing the feasibility of a randomised, double-blinded, placebo-controlled trial to investigate the role of intraperitoneal ropivacaine in gastric bypass surgery: a protocol. BMJ Open. 2014 Aug 11;4(8):e005823. doi: 10.1136/bmjopen-2014-005823. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intraperitoneal Normal Saline | Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection. |
| FG001 | Intraperitoneal Ropivacaine | 200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intraperitoneal Normal Saline | Intraperitoneal Normal Saline: 100mL normal saline administered as in intervention arm prior to dissection. |
| BG001 | Intraperitoneal Ropivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 0-1 h Postoperative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | units on a scale | 0-1 hours post operatively |
|
Adverse events were collected up to postoperative day 7
Safety end points are:
Anticipated SAEs include the risks of an anaesthetic, bleeding, wound infection, bowel injury, unexpected leak, pneumothorax, obstruction and general complications such as a thromboembolic events, pneumonia, cardiac events and stroke.
Adverse events are collected on regular intervals until postoperative day 7
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Intraperitoneal Saline: 100mL normal saline administered as in intervention arm |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Joseph Mamazza | The Ottawa Hospital | 613-798-5555 | jmamazza@toh.on.ca |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Normal Saline |
| Drug |
|
|
| 16-20 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | 16-20 hours post operatively |
| 20-24 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | 20-24 hours post operatively |
| 24-32 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | 24-32 hours post operatively |
| 32-40 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | 32-40 hours post operatively |
| 40-48 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | 40-48 hours post operatively |
| 2h Peak Expiratory Flow (PEF) Score |
Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. |
| 2 hours post operatively |
| 4h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | 4 hours post operatively |
| 8h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | 8 hours post operatively |
| 12h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | 12 hours post operatively |
| 16h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | 16 hours post operatively |
| 20h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | 20 hours post operatively |
| 24h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | 24 hours post operatively |
| 32h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | 32 hours post operatively |
| 40h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | 40 hours post operatively |
| 48h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | 48 hours post operatively |
| 6 Minute Walking Distance Post Operative Day 1 (POD1) | 6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome) | Post operative day 1 |
| 6 Minute Walking Distance Post Operative Day 2 (POD2) | 6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome) | Post operative day 2 |
| Postoperative Day 1 Quality of Recovery Questionnaire (QR-40) | 40-item questionnaire provides a global score(Minimum-score 40, Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1, maximum score of 5 for each question.unit is scores on a scale for all questions. Emotional_State:9 questions subscore can range between 9-45 Physical_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical_Independence:5 questions, subscore range between 5-25 Pain:7 questions, subscore range between 5-25 Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of "None of the time (Poor)"and 5 represents the answer"All of the time (Excellent)"Part B, score of 1 represents the answer"All of the time (Excellent)" and 5 represents"None of the time (Poor) | Post operative day 1 |
| 0-1 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to the patient | 0-1 hours post operatively |
| 0-1 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | 0-1 hours post operatively |
| 0-1 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | 0-1 hours post operatively |
| 0-1 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | 0-1 h Postoperative Tramadol consumption |
| 0-1 h Postoperative Fentanyl Consumption | The amount in mcg of Fentanyl administered to patient | 0-1 hours post operatively |
| 1-2 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | 1-2 hours post operatively |
| 1-2 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | 1-2 hours post operatively |
| 1-2 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | 1-2 hours post operatively |
| 1-2 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | 1-2 hours post operatively |
| 1-2 h Postoperative Fentanyl Consumption | The amount in mcg of Fentanyl administered to patient | 1-2 hours post operatively |
| 2-4 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | 2-4 hours post operatively |
| 2-4 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | 2-4 hours post operatively |
| 2-4 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | 2-4 hours post operatively |
| 2-4 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | 2-4 hours post operatively |
| 2-4 h Postoperative Fentanyl Consumption | The amount in mcg of Fentanyl administered to patient | 2-4 hours post operatively |
| 4-12 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | 4-12 hours post operatively |
| 4-12 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | 4-12 hours post operatively |
| 4-12 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | 4-12 hours post operatively |
| 4-12 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | 4-12 hours post operatively |
| 12-24 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | 12-24 hours post operatively |
| 12-24 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | 12-24 hours post operatively |
| 12-24 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | 12-24 hours post operatively |
| 12-24 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | 12-24 hours post operatively |
| 24-48 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | 24-48 hours post operatively |
| 24-48 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | 24-48 hours post operatively |
| 24-48 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | 24-48 hours post operatively |
| 24-48 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | 24-48 hours post operatively |
| Postoperative Day 7-10 Quality of Recovery Questionnaire (QR-40) | 40-item questionnaire provides a global score(Minimum-score 40,Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1,maximum score of 5 for each question.unit is scores on a scale for all questions. Emotional_State:9 questions subscore can range between 9-45 Physical_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical_Independence:5 questions, subscore range between 5-25 Pain:7 questions,subscore range between 5-25 Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of "None of the time (Poor)"and 5 represents the answer"All of the time (Excellent)"Part B, score of 1 represents the answer"All of the time (Excellent)" and 5 represents"None of the time (Poor) | Post operative day 7-10 |
| 6 Minute Walking Distance Post Operative Day 7-10 (POD 7-10) | 6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome) | Post operative day 7-10 (Follow-up Clinic) |
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection.
| BG002 | Total | Total of all reporting groups |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
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| Mean BMI | Mean | Standard Deviation | kg/m^2 |
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| History of Pain Syndromes | Information collected Preoperatively and data indicates the number of participants who had Pain syndromes. | Number | Participants |
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| History of Asthma | Number | Participants |
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| History of Cardiovascular Disease | Number | participants |
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| History of Arthritis | Number | participants |
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| On Diabetic Medications | Number | participants |
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| On Pain Medications | Number | participants |
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| Previous Caesarean section | Number | participants |
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| Previous Laparoscopic Cholecystectomy | Number | participants |
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| Prior Surgery | Number | participants |
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| Intraperitoneal Ropivacaine |
200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) prior to dissection. |
|
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| Primary | 1-2 h Postoperative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | units on a scale | 1-2 hours post operatively |
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| Primary | 2-4 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | units on a scale | 2-4 hours post operatively |
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| Primary | 4-8 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | units on a scale | 4-8 hours post operatively |
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| Primary | 8-12 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | units on a scale | 8-12 hours post operatively |
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| Primary | 12-16 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | units on a scale | 12-16 hours post operatively |
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| Primary | 16-20 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | units on a scale | 16-20 hours post operatively |
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| Primary | 20-24 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | units on a scale | 20-24 hours post operatively |
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| Primary | 24-32 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients being discharged from hospital early or refusing reading; varying the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | units on a scale | 24-32 hours post operatively |
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| Primary | 32-40 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients being discharged from hospital early or refusing reading; varying the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | units on a scale | 32-40 hours post operatively |
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| Primary | 40-48 Hours Post Operative Pain Level | Measured by the Numeric Pain Rating Scale (NRS) with a range of 0-10 where 0 represents No pain at all ( best outcome) and 10 represents Worst possible pain (worst outcome). | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients being discharged from hospital early or refusing reading; varying the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | units on a scale | 40-48 hours post operatively |
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| Secondary | 1h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | L/min | 1 hours post operatively |
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| Secondary | 2h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | L/min | 2 hours post operatively |
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| Secondary | 4h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | L/min | 4 hours post operatively |
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| Secondary | 8h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | L/min | 8 hours post operatively |
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| Secondary | 12h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | L/min | 12 hours post operatively |
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| Secondary | 16h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | L/min | 16 hours post operatively |
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| Secondary | 20h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | L/min | 20 hours post operatively |
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| Secondary | 24h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | L/min | 24 hours post operatively |
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| Secondary | 32h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | L/min | 32 hours post operatively |
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| Secondary | 40h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | L/min | 40 hours post operatively |
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| Secondary | 48h Peak Expiratory Flow (PEF) Score | Measured using the Mini Wright Peak flow meter with a range of 60-800 L/Min where 60 L/Min represents the worst possible score and 800 L/Min represents the best possible score. Value recorded is based on an average of 3 readings at every time point. | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | L/min | 48 hours post operatively |
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| Secondary | 6 Minute Walking Distance Post Operative Day 1 (POD1) | 6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome) | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. The analysis was done and revised by our Statistician | Posted | Mean | Standard Deviation | Meters | Post operative day 1 |
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| Secondary | 6 Minute Walking Distance Post Operative Day 2 (POD2) | 6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome) | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | Meters | Post operative day 2 |
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| Secondary | Postoperative Day 1 Quality of Recovery Questionnaire (QR-40) | 40-item questionnaire provides a global score(Minimum-score 40, Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1, maximum score of 5 for each question.unit is scores on a scale for all questions. Emotional_State:9 questions subscore can range between 9-45 Physical_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical_Independence:5 questions, subscore range between 5-25 Pain:7 questions, subscore range between 5-25 Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of "None of the time (Poor)"and 5 represents the answer"All of the time (Excellent)"Part B, score of 1 represents the answer"All of the time (Excellent)" and 5 represents"None of the time (Poor) | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | Scores on a scale | Post operative day 1 |
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| Secondary | 0-1 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to the patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 0-1 hours post operatively |
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| Secondary | 0-1 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 0-1 hours post operatively |
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| Secondary | 0-1 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 0-1 hours post operatively |
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| Secondary | 0-1 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 0-1 h Postoperative Tramadol consumption |
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| Secondary | 0-1 h Postoperative Fentanyl Consumption | The amount in mcg of Fentanyl administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mcg | 0-1 hours post operatively |
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| Secondary | 1-2 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 1-2 hours post operatively |
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| Secondary | 1-2 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 1-2 hours post operatively |
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| Secondary | 1-2 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 1-2 hours post operatively |
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| Secondary | 1-2 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 1-2 hours post operatively |
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| Secondary | 1-2 h Postoperative Fentanyl Consumption | The amount in mcg of Fentanyl administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mcg | 1-2 hours post operatively |
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| Secondary | 2-4 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 2-4 hours post operatively |
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| Secondary | 2-4 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 2-4 hours post operatively |
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| Secondary | 2-4 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 2-4 hours post operatively |
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| Secondary | 2-4 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 2-4 hours post operatively |
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| Secondary | 2-4 h Postoperative Fentanyl Consumption | The amount in mcg of Fentanyl administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mcg | 2-4 hours post operatively |
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| Secondary | 4-12 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 4-12 hours post operatively |
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| Secondary | 4-12 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 4-12 hours post operatively |
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| Secondary | 4-12 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 4-12 hours post operatively |
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| Secondary | 4-12 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 4-12 hours post operatively |
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| Secondary | 12-24 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 12-24 hours post operatively |
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| Secondary | 12-24 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 12-24 hours post operatively |
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| Secondary | 12-24 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 12-24 hours post operatively |
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| Secondary | 12-24 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 12-24 hours post operatively |
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| Secondary | 24-48 h Postoperative Tylenol Consumption | The amount in mg of Tylenol administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Median | Standard Deviation | mg | 24-48 hours post operatively |
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| Secondary | 24-48 h Postoperative Ketorolac Consumption | The amount in mg of Ketorolac administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 24-48 hours post operatively |
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| Secondary | 24-48 h Postoperative Tramadol Consumption | The amount in mg of Tramadol administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 24-48 hours post operatively |
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| Secondary | 24-48 h Postoperative Dilaudid Consumption | The amount in mg of Dilaudid administered to patient | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | mg | 24-48 hours post operatively |
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| Secondary | Postoperative Day 7-10 Quality of Recovery Questionnaire (QR-40) | 40-item questionnaire provides a global score(Minimum-score 40,Maximum-Score 200, Higher score represent better Quality of recovery of participant in both global and subscores) subscores(summed to total the global score) across five dimensions explained below, in all categories minimum score is 1,maximum score of 5 for each question.unit is scores on a scale for all questions. Emotional_State:9 questions subscore can range between 9-45 Physical_Comfort:12 questions, subscore range between 12-60 Psychological Support:7 questions, subscore range between 7-35 Physical_Independence:5 questions, subscore range between 5-25 Pain:7 questions,subscore range between 5-25 Questionnaire has two parts A and B, In part A, a score of 1 represents the answer of "None of the time (Poor)"and 5 represents the answer"All of the time (Excellent)"Part B, score of 1 represents the answer"All of the time (Excellent)" and 5 represents"None of the time (Poor) | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Early Discharge or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | Scores on a scale | Post operative day 7-10 |
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| Secondary | 6 Minute Walking Distance Post Operative Day 7-10 (POD 7-10) | 6-Minute walk distance (6MWD)-Defined as the distance in (m) an individual is able to walk a long a flat 30 m walkway over six--minute period, with breaks as required. walk testing has been validated in the obese population, clinically significant differences occur when distances of at least 80m occur. 0 m would be the worst possible value for this outcome and the higher the number achieved in the six-minute duration the better (Better outcome) | Overall Number of Participants Analyzed is not consistent with numbers provided Participant Flow module due to patients refusing, Missing Appointment or being unable to provide the reading for outcome during the allocated time frame which could vary the number of results obtained in a specific time frame. | Posted | Mean | Standard Deviation | meters | Post operative day 7-10 (Follow-up Clinic) |
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| 0 |
| 46 |
| 0 |
| 46 |
| EG001 | Intraperitoneal Ropivacaine | The abdomen will be entered and trocars placed in the usual manner. Using a standard suction/irrigation device and tubing, 200mg of Ropivacaine (0.2% Ropivacaine in 100mL Normal Saline) will be instilled into the abdomen at the start of the case, prior to dissection as follows. Under direct visualization, 50mL (of the 100mL) will be infused over the esophageal hiatus. The remaining 50mL will be infused throughout the abdomen. The infusion line will then be flushed with 30mL of Normal Saline to ensure the entire treatment dose is delivered, and no Ropivacaine remains in the tubing. The remainder of the surgery will proceed as usual. Ropivacaine | 0 | 46 | 0 | 46 |
Not provided
Not provided
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |