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

Medical University of Warsaw

Status and phase: Enrolling; Phase 4

Conditions: Postoperative Pain; Postoperative Nausea and Vomiting; Obesity; Opioid Use

Treatments: Drug: Pregabalin 150mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05804591

PreGab LSG

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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90 participants in 2 patient groups, including a placebo group

Multimodal analgesia group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Multimodal analgesia with preemptive pregabalin group

Experimental group

Description:

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

Treatment:

Drug: Pregabalin 150mg