Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients

Not Applicable

Terminated

• Conditions: Obesity; Pain
• Interventions: Drug: Placebo; Drug: Acetaminophen

• Registration Number: NCT01527942
• Lead Sponsor: Trinity Health Of New England

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-02-06
• Study First Posted: 2012-02-07
• Study Start: 2012-03
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-03
• Results First Submitted: 2015-03-17
• Results First Submitted QC: 2015-11-13
• Last Update Submitted: 2015-11-13
• Results First Posted: 2015-12-17
• Last Update Posted: 2015-12-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 2 - Placebo	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.
Arm 1 - Active Drug	Acetaminophen	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.

Primary Outcome Measures

Name	Time	Method
Change in Pain Relief Score on the 5-point Pain Relief Score Between Baseline and 24 Hours	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 Outcome Measures

Name	Time	Method
Change in Pain Intensity on the 10-point Pain Intensity Scale Between Baseline and 24 Hours	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)
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	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.

Trial Locations

Locations (1)

Saint Francis Hospital; 🇺🇸 Hartford, Connecticut, United States