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Clinical Trials in Turkey / NCT06515691
Recruiting Not applicable

Modified Thoracoabdominal Nerve Plane Block In Laparoscopic Sleeve Gastrectomy

NCT06515691 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2025-01-03
Last updated
2025-12-24

Condition(s) studied

ObesityBariatric SurgeryLaparoscopic Sleeve GastrectomyAcute Post Operative Pain

Investigational drug(s) / intervention(s)

M-TAPA blockPostoperative pain management

M-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.

Postoperative 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.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Istanbul Medipol University Mega Hospital Complex Istanbul Bagcilar Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06515691 on ClinicalTrials.gov ↗ ← All trials in Turkey