REduced Pain After Bariatric Surgery - Sleeve Gastrectomy (REPABS-SG)

April 21, 2024 updated by: Vincenzo Bruni, Fondazione Policlinico Universitario Campus Bio-Medico
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00128
        • Fondazione Policlinico Universitario Campus Bio-Medico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LG-TAP
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.
Procedure: LG-TAP block with local anesthetic
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.
Procedure: Port site infiltration
Prior the surgical incision, an infiltration of the laparoscopic access using a total of 10 ml Ropivacaine 0.5% was performed by surgeon
Placebo Comparator: SALINE
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.
Procedure: Port site infiltration
Prior the surgical incision, an infiltration of the laparoscopic access using a total of 10 ml Ropivacaine 0.5% was performed by surgeon
Procedure: LG-TAP block with saline solution
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Score
Time Frame: 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
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Investigators

  • Principal Investigator: Vincenzo Bruni, MD, Fondazione Policlinico Universitario Campus Bio-Medico

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2022

Primary Completion (Actual)

September 21, 2023

Study Completion (Actual)

September 28, 2023

Study Registration Dates

First Submitted

April 21, 2024

First Submitted That Met QC Criteria

April 21, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 21, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAR 89/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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