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

Sponsor

Khon Kaen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05930184

Collaborator

(none)

Enrollment

Location

Arms

11.1

Anticipated Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity Laparoscopic Sleeve Gastrectomy Transversus Abdominis Plane Block Local Wound Infiltration Bupivacine Opioid Use	Procedure: peri-wound Transversus Abdominis Plane Block Procedure: Local wound infiltration	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 29, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Apr 1, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Cumulative morphine use [48hour after intervention]

Secondary Outcome Measures

Post op VAS pain score [48hr after intervention]
length of hospital stay [within admission]
opioid side effect [within admission]
PACU time [1day after intervention]
postop complication [2week after intervention]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Srinagarind hospital	Khon Kaen	Northeastern	Thailand	40000

Sponsors and Collaborators

Khon Kaen University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thanatat panitphong, M.D., Khon Kaen University

ClinicalTrials.gov Identifier:

NCT05930184

Other Study ID Numbers:

HE651586

First Posted:

Jul 5, 2023

Last Update Posted:

Jul 5, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Obesity, Morbid

Wounds and Injuries

Study Results

No Results Posted as of Jul 5, 2023