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Pharmacy stopped dispensing study medication
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Study the effect of the Transversis Abdominis Plane (TAP) block on pain after surgery for obese women undergoing laparoscopic or robotic gynecologic procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP | Experimental | Patients will receive Ropivicaine 0.5% 20cc injectate from a study labeled syringe |
|
| Saline | Placebo Comparator | Patients will receive Normal saline 20cc injectate from a study labeled syringe |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 0.5% 20cc injectate bilaterally | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | Pain assessments by verbal numerical pain score (NPS) at 0, 1 and 2 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable | 0, 1, and 2 hours |
| Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | Pain assessments by verbal numerical pain score (NPS) at 4, 8, 12 and 24 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable | 4hrs, 8hrs, 12hrs, and 24hrs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ja Hyun Shin | Montefiore Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moses Medical Center | The Bronx | New York | 10467 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Transversus Abdominal Plane | Ropivicaine 0.5% 20cc injectate bilaterally Group B |
| FG001 | Saline | Normal saline 20cc injectate bilaterally Group A |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transversus Abdominal Plane (Drug B) | Ropivicaine 0.5% 20cc injectate bilaterally |
| BG001 | Saline (Drug A) | Normal saline 20cc injectate bilaterally |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Postoperative Numeric Pain Rating Score (NPRS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | Pain assessments by verbal numerical pain score (NPS) at 0, 1 and 2 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable | There were 13 participants receiving the Transversus Abdominis Plane TAP (Group B) and 12 participants receiving the placebo Saline (Group A). | Posted | Median | Inter-Quartile Range | score on a scale | 0, 1, and 2 hours |
|
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All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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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 | Group B (TAP Block) | The anesthesiologist performing the TAP block will administer an injectate of either normal saline or the TAP block in a study labeled syringe that will be drawn by an OR staff member not involved in the surgery or analysis of study data. The protocol is as follows-- prior to skin incision, under ultrasound guidance, the abdominal wall muscular layers will be identified. A linear 6-13 MHz ultrasound transducer will be used. Once the plane is clearly identified between the internal oblique and transversus abdominal muscles, a 20cc injectate of saline or Ropivacaine 0.5% will be administered bilaterally under direct visualization at the site target using a 2 or 4 inch stimiplex needle depending on the size of the patient. |
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Limitations of this study include interim analysis with limited sample size, thus it may result in inadequate power. Early termination due to pharmacist refusal to dispense the experimental Rx (no AEs/SAEs recorded). Only an abstract was written.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ja Hyun Shin | Montefiore Medical Center | 718-920-5157 | JASHIN@montefiore.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D050177 | Overweight |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Normal saline 20cc IV bilaterally |
|
|
|
| Primary | Postoperative Numeric Pain Score (NPS) 0-10 Scale; (0 is Equivalent to no Pain; 10 is Equivalent to the Worst Pain Imaginable) | Pain assessments by verbal numerical pain score (NPS) at 4, 8, 12 and 24 hours prior to discharge in the Post Anesthesia Care Unit. The 10 point NPS scale ranges from 0-10 with 0 being equivalent to no pain and a value of 10 being equivalent to the worst pain imaginable | Posted | Median | Inter-Quartile Range | score on a scale | 4hrs, 8hrs, 12hrs, and 24hrs. |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Group A (Saline) | The anesthesiologist performing the TAP block will administer an injectate of either normal saline or the TAP block in a study labeled syringe that will be drawn by an OR staff member not involved in the surgery or analysis of study data. The protocol is as follows-- prior to skin incision, under ultrasound guidance, the abdominal wall muscular layers will be identified. A linear 6-13 MHz ultrasound transducer will be used. Once the plane is clearly identified between the internal oblique and transversus abdominal muscles, a 20cc injectate of saline or Ropivacaine 0.5% will be administered bilaterally under direct visualization at the site target using a 2 or 4 inch stimiplex needle depending on the size of the patient. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D000588 |
| Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| 12 hours |
|
| 24 hours |
|