Recruiting

Acetaminophen

Sponsor:

McLaren Regional Medical Center

Code:

NCT01460667

Conditions

Morbid Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

IV acetaminophen

IV normal saline

Study Details

Brief summary:

Laparoscopic Roux-en-Y gastric bypass (LRYGBP) is a common type of surgery in which length of stay and morbidity is intimately associated with post-operative nausea and vomiting (PONV) and recovery of bowel function. Medications most commonly used to control for post-operative pain are opioid medications, whose well known adverse effects include PONV. Currently, no studied adequate alternative to opiates exists for mild-moderate pain relief without the aforementioned risks.

The primary goal for this study is to evaluate the the administration of pre- and post-operative IV acetaminophen to determine if there is in an overall decrease in the use of opioid analgesics by patient controlled analgesia (PCA) and subsequent decrease in subjective PONV leading to sooner return of bowel function, enabling progression to oral intake and decrease in post-operative length of stay.

Conditions

Morbid Obesity

Study ID

NCT01460667

Start date

Oct, 2011

Status verified date

Oct, 2011

Primary completion date

Oct, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • patients who are scheduled to undergo laparoscopic Roux-en-Y gastric bypass surgery (LRYGBP) under general anesthesia.
  • age 18 to 65 years
  • BMI >35
  • ASA scores 1,2, or 3
  • a negative pregnancy test for female subjects of childbearing age
  • ability to read, understand and provide informed consent to the study procedures
  • ability to read and understand the use of pain and nausea scales (VAS)

Exclusion Criteria:

  • known hypersensitivity to acetaminophen or opioids
  • use of opioid or schedule II medications prior to commencement of the study >7 days
  • those with chronic pain conditions or significant medical disease requiring pain control
  • abnormal liver function (aspartate aminotransferase/alanine aminotransferase/bilirubin > 3X upper limit of normal range, active hepatic disease, clinically significant liver disease, cirrhosis or hepatitis)
  • known or suspected alcohol, drug or opiate abuse or dependence; or participation in other clinical study within 30 days of surgery.

Study Design

Enrollment

85 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: IV acetaminophen

placebo comparator: IV 0.9% normal saline

Interventions

IV acetaminophen

IV acetaminophen 1000 mg (100 mL) every 6 hours over 30 hours

IV normal saline

0.9% normal saline IV, every 6 hours over 30 hours.

Primary outcome measure

  • difference in post-operative opiate consumption (PCA) [ Time Frame: hourly, 30 hours from first dose of study agent ]

Central Contacts and Locations

Central contacts

Christina Lee, B.Sc.

517-505-4640leechr28@msu.edu

Locations

McLaren Regional Medical Center

Recruiting

Flint, Michigan, United States, 48532

Contacts

Christina Lee, B.Sc.

517-505-4640leechr28@msu.edu

Principal Investigator:

Michael Kia, D.O.

More Information

Sponsor

McLaren Regional Medical Center

Last update posted

Oct 27, 2011

Last verified

Oct, 2011

Keywords

  • Laparoscopic Roux-en-Y Gastric Bypass
  • Post-Operative Pain
  • IV Acetaminophen
  • Post-Operative Nausea and Vomiting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McLaren Regional Medical Center on 2011-10-27.