Laparoscopic Guided Peri-wound Transversus Abdominis Plane Block With Bupivacaine Versus Local Wound Infiltration on Post-op Opioid Use in Laparoscopic Sleeve Gastrectomy
Primary Purpose
Morbid Obesity, Laparoscopic Sleeve Gastrectomy, Transversus Abdominis Plane Block
Status
Recruiting
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
peri-wound Transversus Abdominis Plane Block
Local wound infiltration
Sponsored by
About this trial
This is an interventional treatment trial for Morbid Obesity
Eligibility Criteria
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
Sites / Locations
- Srinagarind hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
local wound infiltration
peri-wound Transversus Abdominis Plane Block
Arm Description
0.25% Bupivacaine 20ml was injected into the wound subcutaneous tissue after the laparoscopic port was removed
0.25% Bupivacaine 20ml was injected into the transversus abdominis plane around the wound before the laparoscopic port was removed
Outcomes
Primary Outcome Measures
Cumulative morphine use
Secondary Outcome Measures
Post op VAS pain score
length of hospital stay
opioid side effect
PACU time
postop complication
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05930184
Brief Title
Laparoscopic Guided Peri-wound Transversus Abdominis Plane Block With Bupivacaine Versus Local Wound Infiltration on Post-op Opioid Use in Laparoscopic Sleeve Gastrectomy
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 29, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Laparoscopic Sleeve Gastrectomy, Transversus Abdominis Plane Block, Local Wound Infiltration, Bupivacine, Opioid Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
98 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
local wound infiltration
Arm Type
Active Comparator
Arm Description
0.25% Bupivacaine 20ml was injected into the wound subcutaneous tissue after the laparoscopic port was removed
Arm Title
peri-wound Transversus Abdominis Plane Block
Arm Type
Experimental
Arm Description
0.25% Bupivacaine 20ml was injected into the transversus abdominis plane around the wound before the laparoscopic port was removed
Intervention Type
Procedure
Intervention Name(s)
peri-wound Transversus Abdominis Plane Block
Other Intervention Name(s)
TAP block
Intervention Description
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
Intervention Name(s)
Local wound infiltration
Intervention Description
0.25% bupivacaine 20ml was injected using no24 needle into subcutaneous tissue after the abdominal sheet was sutured.
Primary Outcome Measure Information:
Title
Cumulative morphine use
Time Frame
48hour after intervention
Secondary Outcome Measure Information:
Title
Post op VAS pain score
Time Frame
48hr after intervention
Title
length of hospital stay
Time Frame
within admission
Title
opioid side effect
Time Frame
within admission
Title
PACU time
Time Frame
1day after intervention
Title
postop complication
Time Frame
2week after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thanatat Panitphong, Doctor of Medicine
Phone
+66888868621
Email
thanatat.panitphong@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Suriya Punchai, Assistant Professor
Phone
+6686-8624484
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thanatat Panitphong, Doctor of Medicine
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Srinagarind hospital
City
Khon Kaen
State/Province
Northeastern
ZIP/Postal Code
40000
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pussakorn Pudsri
Phone
+66637520412
Email
patsapa@kku.ac.th
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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).
Learn more about this trial
Laparoscopic Guided Peri-wound Transversus Abdominis Plane Block With Bupivacaine Versus Local Wound Infiltration on Post-op Opioid Use in Laparoscopic Sleeve Gastrectomy
We'll reach out to this number within 24 hrs