IV APAP: Efficacy of IV Acetaminophen in Acute Post-Operative Pain Control in Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP) Patients

Sponsor

McLaren Regional Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01460667

Collaborator

Cadence Pharmaceuticals (Industry)

Enrollment

Location

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Drug: IV acetaminophen Drug: IV normal saline	N/A

Detailed Description

Opioid use during the post-operative period is a highly effective means of treatment for acute pain, however not without its adverse effects including post-operative nausea, vomiting (PONV), constipation, urinary retention, sedation and respiratory depression. Such factors have been implied in the literature to contribute to prolonged post-operative length of stay, delayed return to diet, return of bowel function and increased incidence of ileus. Alternatively, non-opioids, such as acetaminophen, aspirin, NSAIDs, and selective cyclo-oxygenase-2 inhibitors, can be utilized for acute pain, either alone or in combination with opioids. In the bariatric post-surgical population, NSAIDS both oral and IV (Toradol, Ibuprofen) are not recommended due to their potential bleeding tendency, anti-inflammatory effect, and ulcerogenic effect.

The LRYGBP may be classified as a surgery type associated with mild to moderate post-operative pain. Therefore, the mode of pain relief could directly affect the length of stay. The advent of IV acetaminophen serves as a opportunity to investigate in detail the efficacy of this non-opioid medication in the management of acute pain in the immediate post-operative period without the aforementioned adverse effects as expected from traditional opiate medications. A comprehensive approach to this study includes a prospective, double-blinded, randomized controlled trial of subjects who will undergo LRYGBP and randomized to the study agent (IV acetaminophen) or placebo.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Single Center Study of IV Acetaminophen for the Treatment of Post-Operative Pain After Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP)

Study Start Date :

Oct 1, 2011

Anticipated Primary Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: IV acetaminophen	Drug: IV acetaminophen IV acetaminophen 1000 mg (100 mL) every 6 hours over 30 hours
Placebo Comparator: IV 0.9% normal saline	Drug: IV normal saline 0.9% normal saline IV, every 6 hours over 30 hours.

Arm

Intervention/Treatment

Active Comparator: IV acetaminophen

Drug: IV acetaminophen

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

Placebo Comparator: IV 0.9% normal saline

Drug: IV normal saline

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

post-operative subjective pain intensity [every 2 hours, 30 hours from first dose of study agent]
post-operative nausea and vomiting (PONV) [every 2 hours, 30 hours from first dose of study agent]
time to first post-operative drug administration [up to 30 hours from first dose of study agent]
time to return to flatus [up to 30 hours from first dose of study agent]
acceptance of rescue medication [up to 30 hours from first dose of study agent]
time to first request for rescue medication [up to 30 hours from first dose of study agent]
readiness for discharge [up to 72 hours from the first dose of study agent]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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