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NCT05930184 Clinical Trial

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

Opioid Use Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05930184
Other study ID # HE651586
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date April 29, 2023
Est. completion date December 2024

Study information
Verified date April 2024
Source Khon Kaen University
Contact Thanatat Panitphong, Doctor of Medicine
Phone +66888868621
Email thanatat.panitphong@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Recruiting
Enrollment 98
Est. completion date December 2024
Est. primary completion date January 29, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Thailand Srinagarind hospital Khon Kaen Northeastern

Sponsors (1)
Lead Sponsor Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Cumulative morphine use 48hours after intervention
Secondary Post op VAS pain score 48hours after intervention
Secondary length of hospital stay within admission
Secondary opioid side effect within admission
Secondary PACU time 1day after intervention
Secondary postop complication 2weeks after intervention
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