Trials / Recruiting
RecruitingNCT05804591
Pregabalin in the Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy (LSG).
The Effect of Preemptive Oral Pregabalin As an Element of Multimodal Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy. a Randomized, Prospective, Double Blind Study.
- Status
- Recruiting
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 90 (estimated)
- Sponsor
- Medical University of Warsaw · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The aim of this clinical trial is to assess preemptive oral pregabalin administration in the obese patients undergoing laparoscopic sleeve gastrectomy. The main aims of the study are to evaluate postoperative pain treatment and effect on the intraoperative hemodynamical stability. The participants will be divided into 2 groups: with or without preemptive pregabalin administration.
Detailed description
Pregabalin is a GABA analogue that has analgesic, anxiolytic and effects. There are studies indicating that this drug can be used as an element of multimodal analgesia to decrease opioid requirements in postoperative period. Such an effect would be particularly beneficial for patients with obesity scheduled for laparoscopic sleeve gastrectomy, most commonly performed bariatric surgery. The investigators hypothesized that preemptive pregabalin administration may improve quality of postoperative pain score with less incidence of opioid side effects as well as similar or better intraoperative hemodynamical stability.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pregabalin 150mg | Single dose of pregabalin 150mg in a capsule per os 1 hour before start of the operation. |
| DRUG | Placebo | 1 capsule containing placebo per os 1 hour before start of the operation. |
Timeline
- Start date
- 2023-04-24
- Primary completion
- 2025-04-01
- Completion
- 2025-08-01
- First posted
- 2023-04-07
- Last updated
- 2024-09-19
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT05804591. Inclusion in this directory is not an endorsement.