Comparing oral pregabalin and fentanyl for pain relief after surgery
The Effect of Preoperative Oral Pregabalin and Intraoperative Fentanyl on Postoperative Analgesia in Diagnostic Laparoscopic Gynecologic Surgery: a Comparative Study
This study is testing whether taking pregabalin before surgery can help manage pain after laparoscopic gynecologic surgery better than using fentanyl during the procedure.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 21 Years to 45 Years |
| Sex | Female |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT05150795 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of preoperative oral pregabalin versus intraoperative intravenous fentanyl in managing postoperative pain for patients undergoing diagnostic laparoscopic gynecologic surgery. Patients will be randomly assigned to receive either pregabalin or a placebo before surgery, while the control group will receive fentanyl during the procedure. The goal is to assess the analgesic effects and opioid-sparing potential of pregabalin, which may lead to reduced side effects associated with opioid use. The study will involve 80 participants divided into two groups, each receiving different interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults classified as ASA physical status I who are scheduled for diagnostic laparoscopic gynecologic surgery.
Not a fit: Patients with a history of chronic pain, those taking sedatives or analgesics, or individuals with a history of drug/alcohol abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective pain management option for patients undergoing surgery, reducing reliance on opioids.
How similar studies have performed: Previous studies have shown promising results with pregabalin in reducing postoperative pain, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ASA physical status I Exclusion Criteria: * Patients' refusal * use of sedatives, hypnotics, anti-psychotic or antidepressant drugs * history of drug/alcohol abuse * history of chronic pain * daily intake of analgesics * history of epilepsy
Where this trial is running
Cairo
- Ain-Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Study coordinator: Ghada Mohamed Samir, MD
- Email: dr.ghada216@gmail.com
- Phone: 01005043691
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.