Modified Thoracoabdominal Nerve Plane Block In Laparoscopic Sleeve Gastrectomy

Not Applicable

Recruiting

• Conditions: Obesity; Bariatric Surgery; Laparoscopic Sleeve Gastrectomy; Acute Post Operative Pain
• Interventions: Procedure: M-TAPA block; Procedure: Postoperative pain management

• Registration Number: NCT06515691
• Lead Sponsor: Istanbul Medipol University Hospital

Brief 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.

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.

Study Timeline

• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Status Verified: 2025-01
• Study Start: 2025-01-03
• Last Update Submitted: 2025-01-05
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-09-15
• Study Completion: 2025-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group M = M-TAPA Block group	M-TAPA block	M-TAPA block will be performed andd standard postoperaive pain management protocols will be applied.
Group K = control group	Postoperative pain management	Standard postoperative pain management protocols will be applied. No plane block will be applied.
Group M = M-TAPA Block group	Postoperative pain management	M-TAPA block will be performed andd standard postoperaive pain management protocols will be applied.

Primary Outcome Measures

Name	Time	Method
Opioid consumption	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 Outcome Measures

Name	Time	Method
Pain scores	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.
Adverse events	Postoperative 24-hour period	The secondary aim is to compare the adverse events (nausea, vomiting, itching, ect) related to opioid use
Need for rescue analgesia (tramadol)	Postoperative 24-hour period	The secondary aim is to compare rescue analgesia amount used in the postoperative 24 h period.

Trial Locations

Locations (1)

Istanbul Medipol University Mega Hospital Complex; 🇹🇷 Istanbul, Bagcilar, Turkey