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Study Terminated per Principal Investigator's request
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Bariatric patients usually require the use of either intravenous or oral opioid medications. The use of opioids, however, is often associated with side-effects such as nausea, sedation pruritus, urinary retention and respiratory depression with often delay patient discharge. This study makes use of intravenous acetaminophen , a non-opioid analgesic preoperatively to determine if this will decrease the use of opioids post-operatively for pain management in morbidly obese patients undergoing laparoscopic bariatric surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Active Drug | Experimental | Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. |
|
| Arm 2 - Placebo | Placebo Comparator | Preoperative IV Placebo (0.9 Sodium Chloride 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Drug | Intravenous Acetaminophen 1,000 mg IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours | The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline) | baseline and 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours | The 10-point Pain Intensity Scale is self-reported and scores range from 0=no pain to10=worst possible. Change = (24 hour score - baseline) | baseline and 24 hours |
| Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ioannis Raftopoulos, MD | Saint Francis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Francis Hospital | Hartford | Connecticut | 06105 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 - Active Drug | Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. Acetaminophen: Intravenous Acetaminophen 1,000 mg IV |
| FG001 | Arm 2 - Placebo | Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. Placebo: Placebo - IV administration 0.9% 100 ml NaCl |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 - Active Drug | Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. Acetaminophen: Intravenous Acetaminophen 1,000 mg IV |
| BG001 | Arm 2 - Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours | The 5-point Pain Relief Score is self-reported and scores range from 0=none, 1=little, 2=some, 3=a lot, 4=complete. Change = (24 hour score - baseline) | Study was terminated - data were determined to be unusable by IRB due to consent issues. | Posted | baseline and 24 hours |
|
Adverse event data was collected for 24 hours after patients received either active drug or placebo
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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 | Arm 1 - Active Drug | Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. Acetaminophen: Intravenous Acetaminophen 1,000 mg IV |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | MedDRA | Non-systematic Assessment | Investigator determined death not related to study drug; cause of death cardiomyopathy; death occurred (4 days) outside of reporting window as defined by study protocol |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ioannis Raftopoulos, MD | ST. FRANCIS HOSPITAL AND MEDICAL CENTER | IRaftopo@stfranciscare.org |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Placebo | Drug | Placebo - IV administration 0.9% 100 ml Sodium Chloride (NaCl) |
|
The 4-point patient global satisfaction of pain management scale is self-reported and scores range from 0=poor to 3=excellent. Response rate of 3=excellent at 24 hours after baseline. |
| 24 hours after baseline |
Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. Placebo: Placebo - IV administration 0.9% 100 ml NaCl |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.
Placebo: Placebo - IV administration 0.9% 100 ml NaCl
|
| Secondary | Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours | The 10-point Pain Intensity Scale is self-reported and scores range from 0=no pain to10=worst possible. Change = (24 hour score - baseline) | Study was terminated - data were determined to be unusable by IRB due to consent issues. | Posted | baseline and 24 hours |
|
|
| Secondary | Response Rate - of 3=Excellent at Hour 24 Using 4-point Global Satisfaction With Regards to Overall Pain Management Rating Scale 0=Poor to 3= Excellent. | The 4-point patient global satisfaction of pain management scale is self-reported and scores range from 0=poor to 3=excellent. Response rate of 3=excellent at 24 hours after baseline. | Study was terminated - data were determined to be unusable by IRB due to consent issues. | Posted | 24 hours after baseline |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Arm 2 - Placebo | Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours. Placebo: Placebo - IV administration 0.9% 100 ml NaCl | 1 | 18 | 0 | 18 |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| Aniline Compounds |
| D000588 | Amines |