Pregabalin in the Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy (LSG).

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-24

Study Completion Date

2025-08-01

Brief Summary

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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.

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Detailed Description

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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

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Obesity Postoperative Pain Postoperative Nausea and Vomiting Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Multimodal analgesia group

Patients receiving placebo per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 capsule containing placebo per os 1 hour before start of the operation.

Multimodal analgesia with preemptive pregabalin group

Patients receiving pregabalin 150mg per os 1 hour preoperatively and anesthesia with standard, multimodal analgesia afterwards.

Group Type EXPERIMENTAL

Pregabalin 150mg

Intervention Type DRUG

Single dose of pregabalin 150mg in a capsule per os 1 hour before start of the operation.

Interventions

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Pregabalin 150mg

Single dose of pregabalin 150mg in a capsule per os 1 hour before start of the operation.

Intervention Type DRUG

Placebo

1 capsule containing placebo per os 1 hour before start of the operation.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No