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

NCT ID: NCT05930184

Last Updated: 2024-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-29

Study Completion Date

2024-12-31

Brief Summary

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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

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Periwound-TAP block using 0.25%Bupivacain 20ml and local wound infiltration using 0.25%Bupivacain 20ml
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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local wound infiltration

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

Group Type ACTIVE_COMPARATOR

Local wound infiltration

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

peri-wound Transversus Abdominis Plane Block

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Local wound infiltration

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

Intervention Type PROCEDURE

Other Intervention Names

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TAP block

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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Thanatat panitphong

Primary investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thanatat Panitphong, Doctor of Medicine

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Locations

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Srinagarind hospital

Khon Kaen, Northeastern, Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Thanatat Panitphong, Doctor of Medicine

Role: CONTACT

+66888868621

Suriya Punchai, Assistant Professor

Role: CONTACT

+6686-8624484

Facility Contacts

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Pussakorn Pudsri

Role: primary

+66637520412

Other Identifiers

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HE651586

Identifier Type: -

Identifier Source: org_study_id

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