Morbid ObesityPhase 2/3NCT05930184
Laparoscopic Guided Peri-wound Transversus Abdominis Plane Block With Bupivacaine Versus Local Wound Infiltration on Post-op Opioid Use in Laparoscopic Sleeve Gastrectomy
A Phase 2/3 study testing peri-wound Transversus Abdominis Plane Block and Local wound infiltration in people with Morbid Obesity and Laparoscopic Sleeve Gastrectomy, run by Khon Kaen University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Morbid Obesity, Laparoscopic Sleeve Gastrectomy, Transversus Abdominis Plane Block
- What is being tested?
- peri-wound Transversus Abdominis Plane Block and Local wound infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteThailand
- Study dates
- 29 Apr 2023to Dec 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patient undergoing LSG at Sringarind hospital as indicated by Thai guideline
Who cannot join
- Allergic/contraindicated to bupivacaine, morphine, fentanyl, NSAIDs or Nefopam
- Unable to describe pain score Opioid addict
- denied consent
Trial locations and contacts
1 site in 1 country.
Suriya Punchai, Assistant Professor contact
Thailand1 site, 1 recruiting
- Recruiting
Srinagarind hospital
Khon Kaen, Northeastern, 40000
Pussakorn Pudsri, +66637520412, patsapa@kku.ac.th
About this study
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
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
- Conditions
- Morbid Obesity, Laparoscopic Sleeve Gastrectomy, Transversus Abdominis Plane Block, Local Wound Infiltration, Bupivacine, Opioid Use
- Being tested
- peri-wound Transversus Abdominis Plane Block, Local wound infiltration
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peri-wound Transversus Abdominis Plane BlockProcedure or surgery
Also called TAP 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 infiltrationProcedure or surgery
0.25% bupivacaine 20ml was injected using no24 needle into subcutaneous tissue after the abdominal sheet was sutured.
| Study group | Role | What they receive |
|---|---|---|
| local wound infiltration | Active comparator | 0.25% Bupivacaine 20ml was injected into the wound subcutaneous tissue after the laparoscopic port was removed Receives: Procedure: Local wound infiltration |
| peri-wound Transversus Abdominis Plane Block | Experimental | 0.25% Bupivacaine 20ml was injected into the transversus abdominis plane around the wound before the laparoscopic port was removed Receives: Procedure: peri-wound Transversus Abdominis Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative morphine use
Measured: 48hours after intervention
Secondary outcomes (5)
Post op VAS pain score
Measured: 48hours after intervention
length of hospital stay
Measured: within admission
opioid side effect
Measured: within admission
PACU time
Measured: 1day after intervention
postop complication
Measured: 2weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start29 Apr 2023
- Primary completion29 Jan 2024
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Periwound-TAP block using 0.25%Bupivacain 20ml and local wound infiltration using 0.25%Bupivacain 20ml
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanatat panitphong, Khon Kaen University
- Investigators
- Thanatat Panitphong, Doctor of Medicine, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930184
- Sponsor's protocol ID
- HE651586
- Status last verified
- Apr 2024
- First submitted
- 24 Jun 2023
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05930184
- Acronym / sponsor ID
- HE651586
- Conditions
- Morbid Obesity, Laparoscopic Sleeve Gastrectomy, Transversus Abdominis Plane Block, Local Wound Infiltration, Bupivacine, Opioid Use
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 29 Apr 2023 (actual)
- Primary completion
- 29 Jan 2024 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Periwound-TAP block using 0.25%Bupivacain 20ml and local wound infiltration using 0.25%Bupivacain 20ml
| Arm | Type | Receives |
|---|---|---|
| local wound infiltration | Active comparator | Procedure: Local wound infiltration0.25% Bupivacaine 20ml was injected into the wound subcutaneous tissue after the laparoscopic port was removed |
| peri-wound Transversus Abdominis Plane Block | Experimental | Procedure: peri-wound Transversus Abdominis Plane Block0.25% Bupivacaine 20ml was injected into the transversus abdominis plane around the wound before the laparoscopic port was removed |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patient undergoing LSG at Sringarind hospital as indicated by Thai guideline
Key exclusion criteria (3 listed)
- Allergic/contraindicated to bupivacaine, morphine, fentanyl, NSAIDs or Nefopam
- Unable to describe pain score Opioid addict
- denied consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peri-wound Transversus Abdominis Plane BlockAlso: TAP block0.25% 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. | Procedure or surgery | peri-wound Transversus Abdominis Plane Block |
| Local wound infiltration0.25% bupivacaine 20ml was injected using no24 needle into subcutaneous tissue after the abdominal sheet was sutured. | Procedure or surgery | local wound infiltration |
Primary outcome
Cumulative morphine use
Time frame: 48hours after intervention
5 secondary outcomes
Post op VAS pain score
Time frame: 48hours after intervention
length of hospital stay
Time frame: within admission
opioid side effect
Time frame: within admission
PACU time
Time frame: 1day after intervention
postop complication
Time frame: 2weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suriya Punchai, Assistant Professor contact
Thanatat Panitphong, Doctor of Medicine principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing peri-wound Transversus Abdominis Plane Block and Local wound infiltration in people with Morbid Obesity and Laparoscopic Sleeve Gastrectomy, run by Khon Kaen University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thanatat Panitphong, Doctor of Medicine (+66888868621, thanatat.panitphong@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative morphine use (time frame: 48hours after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.