REduced Pain After Bariatric Surgery - Sleeve Gastrectomy

NCT06383234 | Completed DMC

• 1 other identifier: PAR 89/21
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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).

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

  24 hours

Secondary Outcomes (7)

• Morphine Consumption

  24 hours

• Toradol Consumption

  24 hours

• Nausea and/or vomiting

  48 hours

• Lenght of Hospital Stay

  72 hours

• Time to walking

  72 hours

Study Arms (2)

LG-TAP

EXPERIMENTAL

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; Procedure: Port site infiltration

SALINE

PLACEBO COMPARATOR

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: LG-TAP block with saline solution; Procedure: Port site infiltration

Interventions

LG-TAP block with local anesthetic PROCEDURE

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.

LG-TAP

LG-TAP block with saline solution PROCEDURE

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.

SALINE

Port site infiltration PROCEDURE

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; SALINE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead

Study Sites (1)

Fondazione Policlinico Universitario Campus Bio-medico

Rome, 00128, Italy

Location

Related Publications (2)

• Mongelli F, Marengo M, Bertoni MV, Volonte F, Ledingham NS, Garofalo F. Laparoscopic-Assisted Transversus Abdominis Plane (TAP) Block Versus Port-Site Infiltration with Local Anesthetics in Bariatric Surgery: a Double-Blind Randomized Controlled Trial. Obes Surg. 2023 Nov;33(11):3383-3390. doi: 10.1007/s11695-023-06825-7. Epub 2023 Sep 23.

  PMID: 37740830 BACKGROUND

• Ripolles-Melchor J, Sanchez-Santos R, Abad-Motos A, Gimeno-Moro AM, Diez-Remesal Y, Jove-Albores P, Arago-Chofre P, Ortiz-Sebastian S, Sanchez-Martin R, Ramirez-Rodriguez JM, Trullenque-Juan R, Valenti-Azcarate V, Ramiro-Ruiz A, Correa-Chacon OC, Batalla A, Gimeno-Grauwinkel C, Sanahuja-Blasco JM, Gonzalez-Valverde FM, Galan-Menendez P, Diez-Zapirain MJ, Vilallonga R, Zorrilla-Vaca A, Pascual-Bellosta AM, Martinez-Ubieto J, Carrascosa-Miron T, Ruiz-Escobar A, Martin-Garcia-Almenta E, Suarez-de-la-Rica A, Bausili M, Palacios-Cordoba A, Olvera-Garcia MM, Meza-Vega JA, Sanchez-Pernaute A, Abad-Gurumeta A, Ferrando-Ortola C, Martin-Vaquerizo B, Torres-Alfonso JR, Aguado-Sanchez S, Sanchez-Cabezudo-Noguera F, Garcia-Erce JA, Aldecoa C; POWER 3 Study Investigators Group. Higher Adherence to ERAS Society(R) Recommendations is Associated with Shorter Hospital Stay Without an Increase in Postoperative Complications or Readmissions in Bariatric Surgery: the Association Between Use of Enhanced Recovery After Surgery Protocols and Postoperative Complications after Bariatric Surgery (POWER 3) Multicenter Observational Study. Obes Surg. 2022 Apr;32(4):1289-1299. doi: 10.1007/s11695-022-05949-6. Epub 2022 Feb 10.

  PMID: 35143011 RESULT

MeSH Terms

Conditions

Pain; Pain, Postoperative; Acute Pain; Agnosia

Interventions

Anesthetics, Local; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Vincenzo Bruni, MD

  Fondazione Policlinico Universitario Campus Bio-Medico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Invesigator

Study Record Dates

• First Submitted: April 21, 2024
• First Posted: April 25, 2024
• Study Start: January 10, 2022
• Primary Completion: September 21, 2023
• Study Completion: September 28, 2023
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

IT (1)