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:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07456761
Eligibility Criteria:
Inclusion Criteria:
* Age 18-75 years
* ASA physical status I-III
* Scheduled for elective laparoscopic abdominal surgery under general anesthesia (e.g. laparoscopic cholecystectomy, appendectomy, diagnostic/therapeutic laparoscopic procedures without expected conversion to open surgery)
* Ability to understand the NRS pain scale and the study procedures
* Written informed consent obtained
Exclusion Criteria:
* Known allergy or intolerance to pregabalin, gabapentinoids, or study medications
* Chronic opioid use (daily use \>30 mg oral morphine equivalent for \>2 weeks preoperatively)
* Regular use of gabapentin or pregabalin within 30 days
* Severe renal impairment (eGFR \< 30 mL/min/1.73 m²) or on dialysis
* Severe hepatic impairment (Child-Pugh C)
* Uncontrolled epilepsy or other major neurological disorder
* Severe psychiatric disease, alcohol or substance abuse
* Pregnancy or breastfeeding
* Planned postoperative ICU admission for reasons other than routine overnight monitoring
* Conversion to open abdominal surgery (these patients will be analyzed in sensitivity or excluded, predefined in analysis plan)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07456761
Study Brief:
Protocol Section:
NCT07456761