Effect of Intravenous Acetaminophen on Postoperative Pain of Morbidly Obese Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Placebo-Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Acetaminophen
- Conditions
- Obesity
- Sponsor
- Trinity Health Of New England
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours
- Status
- Terminated
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: Acetaminophen
Arm 2 - Placebo
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.
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours
Time Frame: 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)
Secondary Outcomes
- Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours(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.(24 hours after baseline)