Clinical trial

Modified Thoracoabdominal Nerve Plane Block In Laparoscopic Sleeve Gastrectomy

Recruiting now · Not applicable · 1 countries · Registry ID NCT06515691

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Bariatric Surgery, Laparoscopic Sleeve Gastrectomy, Acute Post Operative Pain

Full registry 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

Treatments and study arms

M-TAPA block

Procedure

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

Procedure

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.

Primary outcomes

Opioid consumptionChanges from baseline opioid consumption at postoperative 0, 2, 4, 8, 16, and 24 hours

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

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Istanbul Medipol University Mega Hospital Complex🌐 Istanbul, Bagcilar, Turkey (Türkiye)

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Ayse Ince, Assist Prof, MDContact

Email · Call +905366774988