REduced Pain After Bariatric Surgery - Sleeve Gastrectomy

Pain Clinical Trial

— REPABS-SG  

Official title:

REduced Pain After Bariatric Surgery - Sleeve Gastrectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06383234
• Other study ID #: PAR 89/21
• Status: Completed
• Phase: N/A
• Start date: January 10, 2022
• Est. completion date: September 28, 2023

Study information

• Verified date: April 2024
• Source: Fondazione Policlinico Universitario Campus Bio-Medico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: September 28, 2023
• Est. primary completion date: September 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario Campus Bio-medico	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Campus Bio-Medico

Country where clinical trial is conducted

Italy, 

References & 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. — View Citation

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 — View Citation

Outcome

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