Visual Analogue ScaleNCT06925945
Modified Thoracoabdominal Plane Block and Rectus Block Combination
A study testing regional anestesia in people with Visual Analogue Scale, run by Haseki Training and Research Hospital.
Trial summary
The aim of our study was to investigate the effect of the combination of Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block with local infiltration analgesia on postoperative pain scores and opioid use. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Visual Analogue Scale
- What is being tested?
- regional anestesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2025to 15 Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old
- ASA1-2
- Laparoscopic cholecystectomy cases
Who cannot join
- Bleeding disorders
- Anticoagulant use
- Patients with previous nerve damage
- Lack of patient consent
- Patients with liver and kidney failure
- Patients allergic to local anesthetics used
- Patients with BMI > 35
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Pain Between Modified Thoracoabdominal Plane Block and Rectus Block Combination and Intraperitoneal Local Infiltration Analgesia
The aim of our study was to investigate the effect of the combination of Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block with local infiltration analgesia on postoperative pain scores and opioid use.
- Conditions
- Visual Analogue Scale
- Being tested
- regional anestesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
regional anestesiaProcedure or surgery
Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block with local infiltration analgesia
| Study group | Role | What they receive |
|---|---|---|
| Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block | Active comparator | Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block Receives: Procedure: regional anestesia |
| local infiltration analgesia | Active comparator | local infiltration analgesia Receives: Procedure: regional anestesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue scale
Pain score measured using a 0-10 scale, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start10 Apr 2025 (estimated)
- Primary completion10 Aug 2025 (estimated)
- Study completion15 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Visual Analogue ScaleStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Hüseyin Demir, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06925945
- Sponsor's protocol ID
- HASEKİ TEZ
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gungor H, Ciftci B, Alver S, Golboyu BE, Ozdenkaya Y, Tulgar S. Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs local infiltration for pain management after laparoscopic cholecystectomy surgery: a randomized study. J Anesth. 2023 Apr;37(2):254-260. doi: 10.1007/s00540-022-03158-0. Epub 2022 Dec 28.
PubMed 36575362Erten E, Kara U, Simsek F, Oztas M, Suzer MA, Kamburoglu H, Eskin MB, Senkal S, Cosar A. Modified thoracoabdominal nerves block through perichondrial approach for laparoscopic cholecystectomy. Rev Assoc Med Bras (1992). 2024 Apr 22;70(3):e20230962. doi: 10.1590/1806-9282.20230962. eCollection 2024.
PubMed 38655995
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pain Between Modified Thoracoabdominal Plane Block and Rectus Block Combination and Intraperitoneal Local Infiltration Analgesia
- ClinicalTrials.gov ID
- NCT06925945
- Acronym / sponsor ID
- HASEKİ TEZ
- Conditions
- Visual Analogue Scale
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Apr 2025 (estimated)
- Primary completion
- 10 Aug 2025 (estimated)
- Study completion
- 15 Aug 2025 (estimated)
- First posted
- 13 Apr 2025 (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 aim of our study was to investigate the effect of the combination of Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block with local infiltration analgesia on postoperative pain scores and opioid use.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block | Active comparator | Procedure: regional anestesiaModified thoracoabdominal plane block (M-TAPA) and rectus sheath block |
| local infiltration analgesia | Active comparator | Procedure: regional anestesialocal infiltration analgesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 18 years old
- ASA1-2
- Laparoscopic cholecystectomy cases
Key exclusion criteria (7 listed)
- Bleeding disorders
- Anticoagulant use
- Patients with previous nerve damage
- Lack of patient consent
- Patients with liver and kidney failure
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 |
|---|---|---|
| regional anestesiaModified thoracoabdominal plane block (M-TAPA) and rectus sheath block with local infiltration analgesia | Procedure or surgery | Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block, local infiltration analgesia |
Primary outcome
visual analogue scale
Time frame: 4 month
Pain score measured using a 0-10 scale, where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate worse pain.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Results publication: PubMed 36575362Gungor H, Ciftci B, Alver S, Golboyu BE, Ozdenkaya Y, Tulgar S. Modified thoracoabdominal nerve block through perichondrial approach (M-TAPA) vs local infiltration for pain management after laparoscopic cholecystectomy surgery: a randomized study. J Anesth. 2023 Apr;37(2):254-260. doi: 10.1007/s00540-022-03158-0. Epub 2022 Dec 28.
- Results publication: PubMed 38655995Erten E, Kara U, Simsek F, Oztas M, Suzer MA, Kamburoglu H, Eskin MB, Senkal S, Cosar A. Modified thoracoabdominal nerves block through perichondrial approach for laparoscopic cholecystectomy. Rev Assoc Med Bras (1992). 2024 Apr 22;70(3):e20230962. doi: 10.1590/1806-9282.20230962. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing regional anestesia in people with Visual Analogue Scale, run by Haseki Training and Research Hospital.
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 3 inclusion and 7 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: opening soon, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ALİ HÜSEYİN DEMİR (+905062958099, alihdemir92@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue scale (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06925945, which also lists 2 linked publications.
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 17 Apr 2025.