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

Comparison of Laparoscopic Guided Peri-wound Transversus Abdominis Plane Block With Bupivacaine Versus Local Wound Infiltration on Post-op Opioid Use in Laparoscopic Sleeve Gastrectomy, A Prospective Randomized Controlled Study

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

Study Overview

• Status: Recruiting
• Conditions: Morbid Obesity; Opioid Use; Laparoscopic Sleeve Gastrectomy; Transversus Abdominis Plane Block; Local Wound Infiltration; Bupivacine
• Intervention / Treatment: Procedure: Local wound infiltration; Procedure: peri-wound Transversus Abdominis Plane Block

• Study Type: Interventional
• Enrollment (Estimated): 98
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Thanatat Panitphong, Doctor of Medicine; Phone Number: +66888868621; Email: thanatat.panitphong@gmail.com
• Study Contact Backup: Name: Suriya Punchai, Assistant Professor; Phone Number: +6686-8624484

Study Locations

• Thailand
  • Northeastern
    • Khon Kaen, Northeastern, Thailand, 40000
      • Recruiting
      • Srinagarind Hospital
      • Contact: Pussakorn Pudsri; Phone Number: +66637520412; Email: patsapa@kku.ac.th

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: local wound infiltration; 0.25% Bupivacaine 20ml was injected into the wound subcutaneous tissue after the laparoscopic port was removed	Procedure: Local wound infiltration; 0.25% bupivacaine 20ml was injected using no24 needle into subcutaneous tissue after the abdominal sheet was sutured.
Experimental: peri-wound Transversus Abdominis Plane Block; 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; 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.; Other Names: TAP block

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative morphine use	48hours after intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
length of hospital stay	within admission
opioid side effect	within admission
PACU time	1day after intervention
Post op VAS pain score	48hours after intervention
postop complication	2weeks after intervention

Collaborators and Investigators

• Sponsor: Khon Kaen University
• Investigators: Principal Investigator: Thanatat Panitphong, Doctor of Medicine, Khon Kaen University

Study record dates

Study Major Dates

• Study Start (Actual): April 29, 2023
• Primary Completion (Actual): January 29, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 24, 2023
• First Submitted That Met QC Criteria: June 24, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Wounds and Injuries; Obesity, Morbid
• Other Study ID Numbers: HE651586

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: all collected IPD
• IPD Sharing 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
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No