Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Intravenous Acetaminophen on Postoperative Pain of Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Placebo-Controlled Trial

Conditions
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Obesity, Pain

Intervention / Treatment
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* Drug: Acetaminophen
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Morbidly Obese and body mass index (BMI) of 35 Between ages 20-17 Candidates for Laparoscopic Bariatric Surgery Exclusion Criteria: know hypersensitivity to acetaminophen or opioids impairment in liver function renal dysfunction mental retardation

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - Active Drug<br>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. | Drug: Acetaminophen<br>* Intravenous Acetaminophen 1,000 mg IV<br>* Other names: OFIRMEV;|
| Placebo Comparator: Arm 2 - Placebo<br>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. | Drug: Placebo<br>* Placebo - IV administration 0.9% 100 ml Sodium Chloride (NaCl)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain Management