Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT01460667
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01460667
Study Brief:
Protocol Section:
NCT01460667