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RecruitingNCT06515691Updated Dec 24, 2025

Modified Thoracoabdominal Nerve Plane Block In Laparoscopic Sleeve Gastrectomy

An interventional study of M-TAPA block and Postoperative pain management in Obesity, Bariatric Surgery and Laparoscopic Sleeve Gastrectomy, sponsored by Istanbul Medipol University Hospital. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-12-24.

Sponsored by Istanbul Medipol University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Feb 2026, 7 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Ultrasound-guided Modified Thoracoabdominal Nerve Plane Block (M-TAPA) is performed into the costochondral aspect at the 9th-10th costal level by injecting local anesthetics deep into the chondrium. It provides blockage of both the anterior and lateral cutaneous branches of the thoracoabdominal nerve. Studies show that M-TAPA block is effective for postoperative analgesia and other abdominal surgeries, but its effect on patients undergoing LSG surgery has not yet been studied. The hypothesis is that the M-TAPA block performed in patients undergoing Laparoscopic Sleeve Gastrectomy (LSG) Operation would reduce opioid consumption in the first 24 hours period after surgery.

Read the detailed description

LSG is defined as first-line bariatric surgery for patients at high surgical risk with better surgical outcomes. Effective postoperative pain management is essential for early mobilization, and reduction of the risk of morbidity and mortality. Opioids, due to their potent analgesic effects are used as a component of multimodal analgesia in the postoperative period. Despite their advantages, opioids may be related to pulmonary complications such as atelectasis and impaired alveolar gas exchange, apnea; postoperative delayed recovery due to ileus, nausea, and vomiting; and prolonged hospital stay. The use of interfascial plane blocks for pain management has increased recently, as ultrasonography (USG) has become a part of daily routine. Interfascial plane blocks provide effective postoperative analgesia.

Additionally, reducing postoperative opioid consumption helps to provide hemodynamic stability and promote early mobilization. Studies are showing M-TAPA block to be effective for postoperative analgesia for abdominal surgeries, and some studies continued comparing its effect in laparoscopic sleeve gastrectomy with other plane blocks. There are also case reports showing the effectiveness of the M-TAPA block in LSG patients. M-TAPA block's effect on LSG patients has not been studied yet. The investigators hypothesize that the M-TAPA block performed in patients undergoing laparoscopic sleeve gastrectomy would reduce opioid consumption in the first 24-hour period after surgery.

02

Conditions studied

  • Obesity
  • Bariatric Surgery
  • Laparoscopic Sleeve Gastrectomy
  • Acute Post Operative Pain

Keywords

  • ModifiedThoracoabdominal Nerve Plane Block
  • Laparoscopic Sleeve Gastrectomy
  • Bariatric Surgery
  • Acute Postoperative Pain
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Istanbul Medipol University Hospital is the lead sponsor of 350 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria: American Society of Anesthesiologists (ASA) classification II- III Patients Scheduled for LSG under general anesthesia

-

Exclusion Criteria: Patients

  • with a history of bleeding diathesis,
  • receiving anticoagulant treatment,
  • with allergies or sensitivity to drugs used,
  • with an infection on the puncture site
  • with a history of alcohol or drug addiction,
  • with congestive heart failure
  • with liver or kidney disease
  • who do not accept the procedure or participate in the study
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    Group M = M-TAPA Block group

    M-TAPA block will be performed andd standard postoperaive pain management protocols will be applied.

    Procedure: M-TAPA block · Procedure: Postoperative pain management

  • Active comparator
    Group K = control group

    Standard postoperative pain management protocols will be applied. No plane block will be applied.

    Procedure: Postoperative pain management

Interventions

  • ProcedureM-TAPA block

    After the wound closure is completed and the patient is still under genaral anesthesia the M-TAPA block ill be performed. As the patient is in the supine position, the high-frequency linear US probe (11-12 MHz, Vivid Q) and a 22-G 80-mm needle (Stimuplex® Ultra 360®, Braun, USA) will be placed in a sagittal position at the costochondral junction at the level of the 9th and 10th ribs. After the rib and the external oblique, internal oblique, and transversus abdominis muscles are visualized on USG, using an in-plane technique, the block needle will be advanced and the block location will be confirmed by injecting 5 ml of saline between the internal oblique and transversus abdominis muscles. Once the block location is confirmed, 30 ml of 0.25% bupivacaine (Buvicaine ®) will be applied on each side. The total volume will be 60 ml.

  • ProcedurePostoperative pain management

    ibuprofen 400mg (Ibuprofen-PF®) intravenous (IV), and tramadol (Contramal®) 100 mg IV will be administered to all patients 20 minutes before wound closure. After surgery, Ibuprofen 400 mg will be given three times a day. A patient-controlled analgesia (PCA) system containing 10 mcg/ml fentanyl will be provided to all patients without continuous infusion. Patients can administer boluses of 0.35 mcg/kg with a 15-minute lockout period and a maximum dose of 100 mcg per hour. Another anesthesiologist will assess patients after surgery. If the patient's pain score (NRS) is 4 or higher, IV tramadol (Contramal®) 100 mg will be given as a rescue analgesic.

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What researchers measure

Primary outcomes

  1. Opioid consumption

    The primary aim is to compare postoperative opioid consumption from the PCA device.

    Time frame: Changes from baseline opioid consumption at postoperative 0, 2, 4, 8, 16, and 24 hours

Secondary outcomes

  1. Pain scores

    The secondary aim is to compare NRS at the postoperative 24 h. Postoperative pain assessment will be performed using the Numerical Rating Scale (NRS) (0 = no pain, 10 = the most severe pain felt). The NRS scores will be recorded.

    Time frame: Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours

  2. Need for rescue analgesia (tramadol)

    The secondary aim is to compare rescue analgesia amount used in the postoperative 24 h period.

    Time frame: Postoperative 24-hour period

  3. Adverse events

    The secondary aim is to compare the adverse events (nausea, vomiting, itching, ect) related to opioid use

    Time frame: Postoperative 24-hour period

07

Study locations

1 of 1 sites recruiting
  • Istanbul Medipol University Mega Hospital Complex
    Istanbul, Bagcilar, Turkey (Türkiye)
    Recruiting
08

References and documents

Publications

  • Schug SA, Raymann A. Postoperative pain management of the obese patient. Best Pract Res Clin Anaesthesiol. 2011 Mar;25(1):73-81. doi: 10.1016/j.bpa.2010.12.001. PubMed 21516915 ↗
  • Jackson TD, Hutter MM. Morbidity and effectiveness of laparoscopic sleeve gastrectomy, adjustable gastric band, and gastric bypass for morbid obesity. Adv Surg. 2012;46:255-68. doi: 10.1016/j.yasu.2012.05.002. PubMed 22873044 ↗
  • Benyamin R, Trescot AM, Datta S, Buenaventura R, Adlaka R, Sehgal N, Glaser SE, Vallejo R. Opioid complications and side effects. Pain Physician. 2008 Mar;11(2 Suppl):S105-20. PubMed 18443635 ↗
  • Tulgar S, Selvi O, Thomas DT, Deveci U, Ozer Z. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides effective analgesia in abdominal surgery and is a choice for opioid sparing anesthesia. J Clin Anesth. 2019 Aug;55:109. doi: 10.1016/j.jclinane.2019.01.003. Epub 2019 Jan 9. No abstract available. PubMed 30639940 ↗
  • Ciftci B, Gungor H, Alver S, Akin AN, Ozdenkaya Y, Tulgar S. Clinical Experience for Modified Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Five Patients. Dermatomal Evaluation and Application of Different Volumes: A Case Series and Review of Literature. Turk J Anaesthesiol Reanim. 2023 Aug 18;51(4):354-357. doi: 10.4274/TJAR.2022.221042. PubMed 37587679 ↗
  • Aikawa K, Tanaka N, Morimoto Y. Modified thoracoabdominal nerves block through perichondrial approach (M-TAPA) provides a sufficient postoperative analgesia for laparoscopic sleeve gastrectomy. J Clin Anesth. 2020 Feb;59:44-45. doi: 10.1016/j.jclinane.2019.06.020. Epub 2019 Jun 15. No abstract available. PubMed 31212124 ↗

Individual participant data

Plan to share: No — The investigators will not share individual patient data (IPD).

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06515691
Lead sponsor
Istanbul Medipol University Hospital
Responsible party
Ayse Ince (Assist Prof, Istanbul Medipol University Hospital) — Principal investigator
First posted
Jul 23, 2024
Start date
Jan 3, 2025
Primary completion
Feb 15, 2026 (estimated)
Completion
Feb 15, 2026 (estimated)
Last update
Dec 24, 2025

Study contacts

ayşe ince, assist pof
Contact
drayseince@gmail.com
+90 5366774988

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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