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

NCT05804591 | Recruiting Phase 4

• 1 other identifier: PreGab LSG
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

Laparoscopic sleeve gastrectomy; Obesity; Pregabalin; Multimodal analgesia

Outcome Measures

Primary Outcomes (5)

• Total postoperative oxycodone consumption

  PCA (Patient's controlled analgesia) iv pump, oxycodone will be administered on patient's demand by 2mg boli, with lock out time 10 minutes

  Day "0"

• Postoperative pain score in NRS scale

  NRS range from 0 for no pain to 10 for worst pain imaginable

  Day "0", assessed 1 hour after operation

• Postoperative pain score in NRS scale

  NRS range from 0 for no pain to 10 for worst pain imaginable

  Day "0", assessed 6 hour after operation

• Postoperative pain score in NRS scale

  NRS range from 0 for no pain to 10 for worst pain imaginable

  Day "0", assessed 12 hour after operation

• Postoperative pain score in NRS scale

  NRS range from 0 for no pain to 10 for worst pain imaginable

  Day "0", assessed 24 hour after operation

Secondary Outcomes (11)

• Postoperative sedation score

  Day "0", assessed 1,6,12 and 24 hours after operation

• Postoperative nausea and vomiting

  Day "0", assessed 1,6,12 and 24 hours after operation

• Highest BP

  intraoperative

• Lowest BP

  intraoperative

• Highest HR

  intraoperative

Study Arms (2)

Multimodal analgesia group

PLACEBO COMPARATOR

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

Drug: Placebo

Multimodal analgesia with preemptive pregabalin group

EXPERIMENTAL

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

Drug: Pregabalin 150mg

Interventions

Pregabalin 150mg DRUG

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

Multimodal analgesia with preemptive pregabalin group

Placebo DRUG

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

Multimodal analgesia group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Szpital Kliniczny Dzieciatka Jezus

Warsaw, Warsaw, 02-005, Poland

RECRUITING

Related Publications (1)

• Mieszczanski P, Gorniewski G, Janiak M, Trzebicki J. The effect of pre-emptive oral pregabalin on opioid consumption in patients undergoing laparoscopic sleeve gastrectomy with an analysis of intraoperative hemodynamic stability and quality of recovery: study protocol for a randomized, prospective, double-blind study. Trials. 2024 Jun 7;25(1):367. doi: 10.1186/s13063-024-08225-3.

  PMID: 38849875 DERIVED

MeSH Terms

Conditions

Obesity; Pain, Postoperative; Postoperative Nausea and Vomiting

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Nausea; Signs and Symptoms, Digestive; Vomiting

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Piotr Mieszczański, MD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Piotr Mieszczański, MD

CONTACT

669643205; piotr.mieszczanski@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: April 7, 2023
• Study Start: April 24, 2023
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)