Laparoscopic Guided Peri-wound Transversus Abdominis Plane Block With Bupivacaine Versus Local Wound Infiltration on Post-op Opioid Use in Laparoscopic Sleeve Gastrectomy

NCT05930184 | Recruiting Phase 2

• 1 other identifier: HE651586
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to compare laparoscopic guided peri-wound Transversus Abdominis Plane Block and bupivacaine versus local wound infiltration effect on reducing post-op opioid use in Laparoscopic Sleeve gastrectomy. The main questions it aims to answer are:

• Can laparoscopic guided peri-wound Transversus Abdominis Plane Block reduced post operative morphine usage when comparing with local wound port site infiltration. Participants will be randomize into 2 group
• peri-wound Transversus Abdominis Plane Block
• local wound port site infiltration

Conditions

Morbid Obesity; Laparoscopic Sleeve Gastrectomy; Transversus Abdominis Plane Block; Local Wound Infiltration; Bupivacine; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Cumulative morphine use

  48hours after intervention

Secondary Outcomes (5)

• Post op VAS pain score

  48hours after intervention

• length of hospital stay

  within admission

• opioid side effect

  within admission

• PACU time

  1day after intervention

• postop complication

  2weeks after intervention

Study Arms (2)

local wound infiltration

ACTIVE COMPARATOR

0.25% Bupivacaine 20ml was injected into the wound subcutaneous tissue after the laparoscopic port was removed

Procedure: Local wound infiltration

peri-wound Transversus Abdominis Plane Block

EXPERIMENTAL

0.25% Bupivacaine 20ml was injected into the transversus abdominis plane around the wound before the laparoscopic port was removed

Procedure: peri-wound Transversus Abdominis Plane Block

Interventions

peri-wound Transversus Abdominis Plane Block PROCEDURE

0.25% bupivacaine 20ml was injected using no24 needle into a plane between internal oblique muscle and transversus abdominis muscle around every wound 2 cm. from wound opening. The procedure was confirmed by laparoscopic vision and the injection was done before removal of laparoscopic port.

Also known as: TAP block

peri-wound Transversus Abdominis Plane Block

Local wound infiltration PROCEDURE

0.25% bupivacaine 20ml was injected using no24 needle into subcutaneous tissue after the abdominal sheet was sutured.

local wound infiltration

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• patient undergoing LSG at Sringarind hospital as indicated by Thai guideline

You may not qualify if:

• Allergic/contraindicated to bupivacaine, morphine, fentanyl, NSAIDs or Nefopam
• Unable to describe pain score Opioid addict
• denied consent

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Srinagarind hospital

Khon Kaen, Northeastern, 40000, Thailand

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thanatat Panitphong, Doctor of Medicine

  Khon Kaen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thanatat Panitphong, Doctor of Medicine

CONTACT

+66888868621; thanatat.panitphong@gmail.com

Suriya Punchai, Assistant Professor

CONTACT

+6686-8624484

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary investigator

Model Details: Periwound-TAP block using 0.25%Bupivacain 20ml and local wound infiltration using 0.25%Bupivacain 20ml

Study Record Dates

• First Submitted: June 24, 2023
• First Posted: July 5, 2023
• Study Start: April 29, 2023
• Primary Completion: January 29, 2024
• Study Completion: December 1, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis
• Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).

Locations

TH (1)