Plane BlockNCT06934772
Comparison of the Analgesic Efficacy of Subcostal TAP and M-TAPA Blocks in Laparoscopic Sleeve Gastrectomy Surgery
An observational study of Plane Block and Regional Anaesthesia, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective The aim of this study is to compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Plane Block, Regional Anaesthesia, Transversus Abdominis Plane (TAP) Block
- What is being tested?
- M-TAPA and Subcostal TAP
- How many people
- 41 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 15 Mar 2025
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a body mass index (BMI) >35 kg/m², Charlson comorbidity index <4, who had received either a subcostal TAP or M-TAPA block after induction but prior to laparoscopic sleeve gastrectomy surgery were included.
Who may be able to join
- patients with a BMI greater than 35 kg/m²,
- aged between 18 and 65, who are scheduled to undergo LSG surgery.
- Patients will receive either a subcostal TAP or M-TAPA block before surgery. Exclusion Criteria:
- patients with incomplete data
- patients with chronic pain
- patients with preoperative opioid use
- patients with preoperative alcohol/substance use
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Haseki Training and Research Hospital
Istanbul, Sultangazi, 34265
About this study
Official title: Comparison of the Analgesic Efficacy of Subcostal Transversus Abdominis Plane and Modified Thoracoabdominal Nerves Block Through Perichondrial Approach (M-TAPA) Blocks in Laparoscopic Sleeve Gastrectomy Surgery
Objective The aim of this study is to compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG). This will be a retrospective study conducted at Haseki Training and Research Hospital between January and November 2024. The study will include patients with a Body mass index (BMI) greater than 35 kg/m², aged between 18 and 65, who are scheduled to undergo LSG surgery. Patients will receive either a subcostal TAP or M-TAPA block before surgery. Data will be collected from patient records, including intraoperative opioid usage, postoperative analgesic consumption, and pain scores (NRS) assessed at rest and during activity in the first 24 hours. Secondary outcomes will include mobilization times and incidence of postoperative nausea and vomiting (PONV).
Read the detailed description
Objective The aim of this study is to compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG).
Study Design This will be a retrospective study conducted at Haseki Training and Research Hospital between January and November 2024. The study will include patients with a BMI greater than 35 kg/m², aged between 18 and 65, who are scheduled to undergo LSG surgery. Patients will receive either a subcostal TAP or M-TAPA block before surgery. Data will be collected from patient records, including intraoperative opioid usage, postoperative analgesic consumption, and pain scores (NRS) assessed at rest and during activity in the first 24 hours. Secondary outcomes will include mobilization times and incidence of postoperative nausea and vomiting (PONV).
Study Procedures Patients who meet the inclusion criteria will be included in the study, and data will be retrospectively reviewed. Intraoperative hemodynamic data, surgical duration, and total opioid consumption will be collected from anesthesia records. Postoperative analgesic use and pain scores will be assessed from nurse documentation and medical records. Patients with incomplete data or pre-existing chronic pain conditions will be excluded.
Outcome Measures
- Primary Outcome: Comparison of the analgesic efficacy of M-TAPA and subcostal TAP blocks during intraoperative and postoperative periods (first 24 hours).
- Secondary Outcomes: Resting and active NRS pain scores, mobilization times, incidence of nausea and vomiting, and complications related to the block procedures.
- Conditions
- Plane Block, Regional Anaesthesia, Transversus Abdominis Plane (TAP) Block, Bariatric Surgery
- Being tested
- M-TAPA, Subcostal TAP
- Keywords
- perioperative pain management, M-TAPA block, peripheral plane block, pain management, bariatric surgery
- Medical subject headings
- Bites and Stings, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
M-TAPAOther
this study will be compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG).
Subcostal TAPOther
this study will be compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG).
| Study group | Role | What they receive |
|---|---|---|
| M-TAPA Group | Patients who were applied M-TAPA the inclusion criteria will be included in the study, and data will be retrospectively reviewed. Intraoperative hemodynamic data, surgical duration, and total opioid consumption will be collected from anesthesia records. Postoperative analgesic use and pain scores will be assessed from nurse documentation and medical records. Patients with incomplete data or pre-existing chronic pain conditions will be excluded. Receives: Other: M-TAPA | |
| Subcostal TAP Group | Patients who were applied M-TAPA the inclusion criteria will be included in the study, and data will be retrospectively reviewed. Intraoperative hemodynamic data, surgical duration, and total opioid consumption will be collected from anesthesia records. Postoperative analgesic use and pain scores will be assessed from nurse documentation and medical records. Patients with incomplete data or pre-existing chronic pain conditions will be excluded. Receives: Other: Subcostal TAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic Efficacy
Comparison of the analgesic efficacy of M-TAPA and subcostal TAP blocks during intraoperative and postoperative periods.The visual pain score includes values between 0 and 10. o means no pain, 5 means moderate pain, and 10 means severe pain. In the postoperative period, the pain levels of the patients will be compared by looking at this visual pain value. In the intraoperative period, the amount of analgesic consumption (total consumption of remifentanil mcg) will be evaluated.
Measured: Intraoperative periods, postoperative first 24 hours.
Secondary outcomes (1)
Other conditions associated with the block
Resting and active NRS pain scores, mobilization times, nausea and vomiting frequency and complications related to block procedures. Visual pain scores of patients when they first start moving postoperatively will be examined. 0 is evaluated as no pain, 5 as moderate pain, 10 as very severe pain. The time they first started mobilizing will be determined according to the postoperative hour. It will be recorded as whether nausea and vomiting occurred or not. If there were other complications (e.g. bleeding at the block site, hematoma, shortness of breath, pneumothorax), all this information will be determined from the patient files.
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Nov 2024
- Primary completion1 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plane BlockStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Munevver Kayhan, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934772
- Sponsor's protocol ID
- HEA-AAR-MK-04
- Status last verified
- Apr 2025
- First submitted
- 5 Apr 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turunc E, Dost B, Sarikaya Ozel E, Kaya C, Ustun YB, Bilgin S, Ozbalci GS, Koksal E. Bilateral Ultrasound-Guided External Oblique Intercostal Block Vs. Modified Thoracoabdominal Nerve Block Through Perichondrial Approach for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy Surgery: A Randomized Controlled Study. Obes Surg. 2024 Oct;34(10):3726-3734. doi: 10.1007/s11695-024-07454-4. Epub 2024 Sep 11.
PubMed 39259439
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Efficacy of Subcostal Transversus Abdominis Plane and Modified Thoracoabdominal Nerves Block Through Perichondrial Approach (M-TAPA) Blocks in Laparoscopic Sleeve Gastrectomy Surgery
- ClinicalTrials.gov ID
- NCT06934772
- Acronym / sponsor ID
- HEA-AAR-MK-04
- Conditions
- Plane Block, Regional Anaesthesia, Transversus Abdominis Plane (TAP) Block, Bariatric Surgery
- Keywords
- perioperative pain management, M-TAPA block, peripheral plane block, pain management, bariatric surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 18 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.
Objective The aim of this study is to compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG). This will be a retrospective study conducted at Haseki Training and Research Hospital between January and November 2024. The study will include patients with a Body mass index (BMI) greater than 35 kg/m², aged between 18 and 65, who are scheduled to undergo LSG surgery. Patients will receive either a subcostal TAP or M-TAPA block before surgery. Data will be collected from patient records, including intraoperative opioid usage, postoperative analgesic consumption, and pain scores (NRS) assessed at rest and during activity in the first 24 hours. Secondary outcomes will include mobilization times and incidence of postoperative nausea and vomiting (PONV).
Detailed description
Objective The aim of this study is to compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG).
Study Design This will be a retrospective study conducted at Haseki Training and Research Hospital between January and November 2024. The study will include patients with a BMI greater than 35 kg/m², aged between 18 and 65, who are scheduled to undergo LSG surgery. Patients will receive either a subcostal TAP or M-TAPA block before surgery. Data will be collected from patient records, including intraoperative opioid usage, postoperative analgesic consumption, and pain scores (NRS) assessed at rest and during activity in the first 24 hours. Secondary outcomes will include mobilization times and incidence of postoperative nausea and vomiting (PONV).
Study Procedures Patients who meet the inclusion criteria will be included in the study, and data will be retrospectively reviewed. Intraoperative hemodynamic data, surgical duration, and total opioid consumption will be collected from anesthesia records. Postoperative analgesic use and pain scores will be assessed from nurse documentation and medical records. Patients with incomplete data or pre-existing chronic pain conditions will be excluded.
Outcome Measures
- Primary Outcome: Comparison of the analgesic efficacy of M-TAPA and subcostal TAP blocks during intraoperative and postoperative periods (first 24 hours).
- Secondary Outcomes: Resting and active NRS pain scores, mobilization times, incidence of nausea and vomiting, and complications related to the block procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| M-TAPA Group | – | Other: M-TAPAPatients who were applied M-TAPA the inclusion criteria will be included in the study, and data will be retrospectively reviewed. Intraoperative hemodynamic data, surgical duration, and total opioid consumption will be collected from anesthesia records. Postoperative analgesic use and pain scores will be assessed from nurse documentation and medical records. Patients with incomplete data or pre-existing chronic pain conditions will be excluded. |
| Subcostal TAP Group | – | Other: Subcostal TAPPatients who were applied M-TAPA the inclusion criteria will be included in the study, and data will be retrospectively reviewed. Intraoperative hemodynamic data, surgical duration, and total opioid consumption will be collected from anesthesia records. Postoperative analgesic use and pain scores will be assessed from nurse documentation and medical records. Patients with incomplete data or pre-existing chronic pain conditions will be excluded. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a body mass index (BMI) >35 kg/m², Charlson comorbidity index <4, who had received either a subcostal TAP or M-TAPA block after induction but prior to laparoscopic sleeve gastrectomy surgery were included.
Key inclusion criteria (7 listed)
- patients with a BMI greater than 35 kg/m²,
- aged between 18 and 65, who are scheduled to undergo LSG surgery.
- Patients will receive either a subcostal TAP or M-TAPA block before surgery. Exclusion Criteria:
- patients with incomplete data
- patients with chronic pain
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| M-TAPAthis study will be compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG). | Other | M-TAPA Group |
| Subcostal TAPthis study will be compare the analgesic efficacy of bilateral subcostal transversus abdominis plane (TAP) and modified thoracoabdominal (M-TAPA) blocks in reducing intraoperative opioid consumption and postoperative analgesic needs in patients undergoing laparoscopic sleeve gastrectomy (LSG). | Other | Subcostal TAP Group |
Primary outcome
Analgesic Efficacy
Time frame: Intraoperative periods, postoperative first 24 hours.
Comparison of the analgesic efficacy of M-TAPA and subcostal TAP blocks during intraoperative and postoperative periods.The visual pain score includes values between 0 and 10. o means no pain, 5 means moderate pain, and 10 means severe pain. In the postoperative period, the pain levels of the patients will be compared by looking at this visual pain value. In the intraoperative period, the amount of analgesic consumption (total consumption of remifentanil mcg) will be evaluated.
1 secondary outcome
Other conditions associated with the block
Time frame: postoperative 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Results publication: PubMed 39259439Turunc E, Dost B, Sarikaya Ozel E, Kaya C, Ustun YB, Bilgin S, Ozbalci GS, Koksal E. Bilateral Ultrasound-Guided External Oblique Intercostal Block Vs. Modified Thoracoabdominal Nerve Block Through Perichondrial Approach for Postoperative Analgesia in Patients Undergoing Laparoscopic Sleeve Gastrectomy Surgery: A Randomized Controlled Study. Obes Surg. 2024 Oct;34(10):3726-3734. doi: 10.1007/s11695-024-07454-4. Epub 2024 Sep 11.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plane Block and Regional Anaesthesia, run by Haseki Training and Research Hospital at 1 site in Turkey (Türkiye).
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 7 inclusion and 0 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: finished, as of the sponsor's last update on 18 Apr 2025. 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 Turkey (Türkiye). 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic Efficacy (time frame: Intraoperative periods, postoperative first 24 hours.). 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 NCT06934772, which also lists 1 linked publication.
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 18 Apr 2025.