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:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2025-12-24 @ 5:31 PM
NCT ID:
NCT00399568
Eligibility Criteria:
Inclusion Criteria:
* Undergo gynecologic surgery using standard abdominal approach such as midline or Pfannenstiel incision
* 18-75 years of age
* Body Mass Index (BMI) between 19-45
* American Society of Anesthesiologists (ASA) risk class of I, II, III
* Not have received neuraxial (spinal or epidural) opioid analgesics prior to or during surgery
* Moderate to Severe pain at rest
Exclusion Criteria:
* Requires any additional surgical procedures either related or unrelated to gynecologic surgery during same hospitalization
* Procedures involving only minimal incisions such as laparotomy, laparoscopy, supraumbilical or Maylard incisions
* Has know hypersensitivity to opioids, acetaminophen, or the excipients of IV acetaminophen
* Known history of alcohol or drug abuse or misuse
* Has impaired liver function Aspartate transaminase(AST), Alanine aminotransferase(ALT), bilirubin greater than or equal to 2 times upper limit of normal
* Has significant medical disease(s), or conditions that may contraindicate participation in the study
* Has participated in another clinical trial within 30 days of surgery
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT00399568
Study Brief:
Protocol Section:
NCT00399568