Status:
UNKNOWN
Efficacy of IV Acetaminophen in Acute Post-Operative Pain Control in Laparoscopic Roux-en-Y Gastric Bypass Surgery (LRYGBP) Patients
Lead Sponsor:
McLaren Regional Medical Center
Collaborating Sponsors:
Cadence Pharmaceuticals
Conditions:
Morbid Obesity
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
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), constipat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT01460667
Start Date
October 1 2011
Last Update
October 27 2011
Active Locations (1)
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1
McLaren Regional Medical Center
Flint, Michigan, United States, 48532