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NCT Number: NCT06515691

Modified Thoracoabdominal Nerve Plane Block In Laparoscopic Sleeve Gastrectomy

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.

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Key information

Conditions

Obesity Acute Post Operative Pain Bariatric Surgery Body Weight Laparoscopic Sleeve Gastrectomy Neurologic Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Medipol University Mega Hospital Complex

Istanbul, Bagcilar, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ayse Ince, Assist Prof, MD

CONTACT

[email protected]

+905366774988

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. Opioid consumption

    Time frame: Changes 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.

Secondary outcomes

  1. Pain scores

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

    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.

  2. Need for rescue analgesia (tramadol)

    Time frame: Postoperative 24-hour period

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

  3. Adverse events

    Time frame: Postoperative 24-hour period

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

Study contacts

Contact information is provided by the study sponsor or research team.

ayşe ince, assist pof

CONTACT

[email protected]

+90 5366774988

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Registry information

Official study title

Evaluation of Effectiveness of Ultrasound-Guided Modified Thoracoabdominal Nerve Plane Block Through Perichondrial Approach (M-TAPA) for Postoperative Analgesia Management in Patients Undergoing Laparoscopic Sleeve Gastrectomy Operation

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2024
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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