Intravenous Acetaminophen Use With Bariatric Surgery on Morbidly Obese Patients

November 13, 2015 updated by: Saint Francis Care

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06105
        • Saint Francis Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Acetaminophen
Intravenous Acetaminophen 1,000 mg IV
Other Names:
  • OFIRMEV
Placebo Comparator: 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.
Drug: Placebo
Placebo - IV administration 0.9% 100 ml Sodium Chloride (NaCl)

What is the study measuring?

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
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)
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
Time Frame: 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.
Time Frame: 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.
24 hours after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Francis Care

Investigators

  • Principal Investigator: Ioannis Raftopoulos, MD, Saint Francis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

February 2, 2012

First Submitted That Met QC Criteria

February 6, 2012

First Posted (Estimate)

February 7, 2012

Study Record Updates

Last Update Posted (Estimate)

December 17, 2015

Last Update Submitted That Met QC Criteria

November 13, 2015

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-01-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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