REduced Pain After Bariatric Surgery - Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Acute Pain; Postoperative Pain; Analgesia; Pain; Bariatric Surgery Candidate; Anesthesia

• Registration Number: NCT06383234
• Lead Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

Brief Summary

This study aims to analyze the effect of laparoscopic guided transversus abdominis plane (LG-TAP) block compared to placebo for postoperative analgesia following laparoscopic sleeve gastrectomy. One group of participants received a (LG-TAP) block with local anesthetic while the other group received (LG-TAP) block with saline solution (placebo).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-10
• Primary Completion: 2023-09-21
• Study Completion: 2023-09-28
• Status Verified: 2024-04
• Study First Submitted: 2024-04-21
• Study First Submitted QC: 2024-04-21
• Last Update Submitted: 2024-04-21
• Study First Posted: 2024-04-25
• Last Update Posted: 2024-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• Elective Laparoscopic Sleeve Gastrectomy
• Body Mass Index (BMI) > 35 kg/m² and at least one condition related to obesity (e.g., hypertension, type II diabetes, dyslipidemia, hepatic steatosis, etc)
• BMI > 40 kg/m², even in the absence of comorbidities
• ASA physical status score < 4

Exclusion Criteria

• ASA physical status score ≥ 4
• Patient's refusal or inability to sign the informed consent
• Allergies to any drug provided by the study protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain Score	24 hours	A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
Nausea and/or vomiting	48 hours	Incidence of nausea and/or vomiting
Time to walking	72 hours	Time between surgery and patient starting to walk
Surgical Complication	7 days	Incidence of complications related to surgery
Time to first flatus	72 hours	Time between surgery and patient having flatus
Morphine Consumption	24 hours	Total of intravenous morphine (expressed in milligrams) administered administered during the first 24 hours after surgery
Toradol Consumption	24 hours	Total of intravenous toradol (expressed in milligrams) administered administered during the first 24 hours after surgery
Lenght of Hospital Stay	72 hours	Time between surgery and dismission from the hospital

Trial Locations

Locations (1)

Fondazione Policlinico Universitario Campus Bio-medico; 🇮🇹 Rome, Italy