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 @ 9:28 PM
Ignite Modification Date:
2025-12-24 @ 9:28 PM
NCT ID:
NCT00728832
Eligibility Criteria:
Inclusion Criteria:
* Males and females ≥ 18 years of age at Screening
* Negative pregnancy test in females of childbearing potential
* Scheduled for major upper abdominal surgery via an upper midline incision under general anesthesia
* American Society of Anesthesiology (ASA) Physical Class 1, 2, or 3
* Willing and able to use a PCA pump
* Willing to receive only IV fentanyl for 72 hours post-dose to control post-operative pain
* Capable of providing written informed consent and responses to pain assessment scales and neurological assessment questionnaires
Exclusion Criteria:
* Morbid obesity, defined as a body mass index (BMI) ≥ 40
* Scheduled to undergo surgery under regional anesthesia
* Usage of analgesic medications containing morphine or codeine within three days prior to study drug administration
* Chronic opioid medication usage (defined as daily opioids for more than 7 days prior to enrollment)
* Suspected or documented history of sleep apnea, narcolepsy, or excessive daytime sleepiness
* Female who was pregnant or lactating
* History of hypersensitivity or idiosyncratic reaction to opioid medications, local anesthetics, or epinephrine
* Any contraindication for the epidural administration of study drug (e.g., coagulopathy, local infection)
* Administration of an investigational drug within 30 days prior to Screening
* Suspected or documented history of substance abuse and/or alcoholism
* Any contraindication to frequent blood PK sampling (such as significant anemia) or other barrier to obtaining timely PK samples
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00728832
Study Brief:
Protocol Section:
NCT00728832