Using pregabalin to manage pain in obese patients undergoing laparoscopic sleeve gastrectomy
The Effect of Preemptive Oral Pregabalin As an Element of Multimodal Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy. a Randomized, Prospective, Double Blind Study.
This study is testing if taking pregabalin before surgery can help reduce pain and the need for opioids in obese patients having laparoscopic sleeve gastrectomy.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Warsaw Academic / other |
| Locations | 1 site (Warsaw, Warsaw) |
| Trial ID | NCT05804591 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of preemptive oral pregabalin on postoperative pain management in obese patients undergoing laparoscopic sleeve gastrectomy. Participants will be divided into two groups: one receiving pregabalin and the other receiving a placebo. The study aims to assess the impact of pregabalin on pain scores and opioid use, as well as its effect on intraoperative hemodynamic stability. The hypothesis is that pregabalin will reduce the need for opioids and improve overall postoperative outcomes.
Who should consider this trial
Good fit: Ideal candidates are obese patients with a BMI over 40 or over 35 with comorbidities who are scheduled for laparoscopic sleeve gastrectomy.
Not a fit: Patients who refuse participation, have allergies to the study medication, or have end-stage organ failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved pain management and reduced opioid use in obese patients after surgery.
How similar studies have performed: Previous studies have indicated that pregabalin can effectively reduce opioid requirements in postoperative settings, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Sleeve gastrectomy in patients with BMI \> 40 or \>35 with comorbidities * Written informed consent Exclusion Criteria: * Patient's refusal * Known allergies to study medication * Inability to comprehend or participate In pain scoring scale * Inability to use intravenous patient controlled analgesia * Changes of operation extent during procedure * Revisional operations * End stage organ failure
Where this trial is running
Warsaw, Warsaw
- Szpital Kliniczny Dzieciatka Jezus — Warsaw, Warsaw, Poland (Recruiting)
Study contacts
- Principal investigator: Piotr Mieszczański, MD — Medical University of Warsaw
- Study coordinator: Piotr Mieszczański, MD
- Email: piotr.mieszczanski@gmail.com
- Phone: 669643205
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.