REduced Pain After Bariatric Surgery - Gastric Bypass (REPABS-BPG)

Fondazione Policlinico Universitario Campus Bio-Medico

Status: Completed

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

Treatments: Procedure: Port site infiltration; Drug: LG-TAP block with saline solution; Drug: LG-TAP block with local anesthetic

Study type: Interventional

Funder types: Other

Identifiers

NCT06614257

PAR 90/21

Details and patient eligibility

About

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

Enrollment: 84 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Elective Laparoscopic Gastric Bypass
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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84 participants in 2 patient groups, including a placebo group

LG-TAP

Experimental group

Description:

The laparoscopic guided TAP Block was performed at the beginning of surgery, injecting 15 ml of Local Anesthetic (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.

Treatment:

Drug: LG-TAP block with local anesthetic

Procedure: Port site infiltration

PLACEBO

Placebo Comparator group

Description:

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.

Treatment:

Drug: LG-TAP block with saline solution

Procedure: Port site infiltration