Clinical trial

The Effect of Preemptive Oral Pregabalin as an Element of Multimodal Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy. A Randomized, Prospective, Double Blind Study.

Name

PreGab LSG

Description

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.

Trial arms

Trial start

2023-04-24

Estimated PCD

2025-04-01

Trial end

2025-08-01

Status

Recruiting

Phase

Early phase I

Treatment

Pregabalin 150mg

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

Arms:

Multimodal analgesia with preemptive pregabalin group

Placebo

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

Arms:

Multimodal analgesia group

Size

Primary endpoint

Total postoperative oxycodone consumption

Day "0"

Postoperative pain score in NRS scale

Day "0", assessed 1 hour after operation

Postoperative pain score in NRS scale

Day "0", assessed 6 hour after operation

Postoperative pain score in NRS scale

Day "0", assessed 12 hour after operation

Postoperative pain score in NRS scale

Day "0", assessed 24 hour after operation

Eligibility 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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 90, 'type': 'ESTIMATED'}}

Updated at

2023-04-27

1 organization

1 product

1 drug

4 indications

Organization

Medical University of Warsaw

Product

Pregabalin

Indication

Obesity