REduced Pain After Bariatric Surgery - Sleeve Gastrectomy

Not Applicable

Completed

• Conditions: Acute Pain; Postoperative Pain; Analgesia; Pain; Bariatric Surgery Candidate; Anesthesia
• Interventions: Procedure: LG-TAP block with saline solution; Procedure: LG-TAP block with local anesthetic; Procedure: Port site infiltration

• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SALINE	Port site infiltration	The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Saline solution (NaCl 0.9%) on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.
SALINE	LG-TAP block with saline solution	The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Saline solution (NaCl 0.9%) on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.
LG-TAP	Port site infiltration	The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Ropivacaine Hydrochloride 0.5% on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.
LG-TAP	LG-TAP block with local anesthetic	The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Ropivacaine Hydrochloride 0.5% on each side, using an atraumatic needle (10/15 cm length, 20 Gauge diameter) close to the anterior axillary line, between the iliac crest and the subcostal margin. Correct needle tip positioning between the transverse muscle of the abdomen and the internal oblique was verified through laparoscopic guidance.

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
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
Nausea and/or vomiting	48 hours	Incidence of nausea and/or vomiting
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