RecruitingPhase 4NCT05804591

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.


Sponsor

Medical University of Warsaw

Enrollment

90 participants

Start Date

Apr 24, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Sleeve gastrectomy in patients with BMI > 40 or >35 with comorbidities
  • Written informed consent

Exclusion Criteria7

  • 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

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Interventions

DRUGPregabalin 150mg

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

DRUGPlacebo

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


Locations(1)

Szpital Kliniczny Dzieciatka Jezus

Warsaw, Warsaw, Poland

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NCT05804591


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