REduced Pain After Bariatric Surgery - Gastric Bypass

Fondazione Policlinico Universitario Campus Bio-Medico84 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Pain Postoperative Pain Acute Pain Analgesia Bariatric Surgery Candidate Anesthesia

Interventions

LG-TAP block with local anestheticDRUG

The laparoscopic guided TAP Block was performed by surgeon at the beginning of surgery, injecting 15 ml of Ropivacaine 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.

Port site infiltrationPROCEDURE

Prior the surgical incision, an infiltration of the laparoscopic access using a total of 10 ml Ropivacaine 0.5% was performed by surgeon

LG-TAP block with saline solutionDRUG

The laparoscopic guided TAP Block was performed by surgeon 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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Fondazione Policlinico Universitario Campus Bio-medico

Rome, Italy

Outcomes

Primary Outcomes

Pain Score

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

Time frame: 24 hours

Secondary Outcomes

Morphine Consumption

Total of intravenous morphine (expressed in milligrams) administered administered during the first 24 hours after surgery

Time frame: 24 hours

Ketorolac Consumption

Total of intravenous toradol (expressed in milligrams) administered administered during the first 24 hours after surgery

Time frame: 24 hours

Nausea and/or Vomiting

Incidence of nausea and/or vomiting

Time frame: 48 hours

Length of Hospital Stay

Time between surgery and dismission from the hospital

Time frame: 72 hours

Timt to walking

Time between surgery and patient starting to walk

Time frame: 72 hours

Time to first flatus

Time between surgery and patient having flatus

Time frame: 72 hours

Surgical Complications

Incidence of complications related to surgery

Time frame: 7 days

Data from ClinicalTrials.gov

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