NCT07510347

Perioperative Analgesic Effect of Different Volumes of Modified Thoracoabdominal Perichondrial Approach on Patients Undergoing Sleeve Gastrectomy: Prospective Randomized Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Menoufia University · Academic / Other
• Sex: All
• Age: 20 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Sleeve gastrectomy is a leading technique in metabolic \& bariatric surgery. It gained ever-increasing popularity among laparoscopic bariatric surgeries and has proved to be a successful method in achieving considerable weight loss in a short time . Postoperative pain management can be obtained by opioids, opioid free analgesics and/or regional blocks. Regional techniques, like Transverse abdominis plane block (TAP) blocks or Modified Thoracoabdominal Nerve Block through perichondrial approach (M-TAPA), offer targeted pain relief, reduce the need for opioids, and promote faster recovery. Compared to systemic opioids, regional blocks are more effective in managing postoperative pain while minimizing complications and enhancing recovery after surgery . M-TAPA was developed by Tulgar et al. as a targeted method for managing postoperative pain in patients undergoing abdominal surgeries. This innovative technique utilizes a perichondrial approach, where a local anesthetic is administered to the lower surface of the chondrium . This method is particularly beneficial because it allows the anesthetic to spread widely, effectively covering multiple dermatomal levels, specifically T5 and T11-12. The diffusion of the local anesthetic across the linea semilunaris contributes to a broader analgesic effect, which is crucial for comprehensive pain management in this surgical context . The feasibility of doing the block in a supine position is making it a practical option for both patients and surgeons during procedures. This accessibility can streamline the surgical workflow and enhance patient comfort . Moreover, it plays a great role in Enhanced Recovery After Bariatric Surgery (ERABS) protocols . Twenty, 25, and 30-mL volumes of 0.25% bupivacaine per side were used in case reports and single-group studies . However, so far no available studies compared different volumes of M-TAPA block abdominal surgeries. The aim of this study is to assess the perioperative analgesic efficacy of different volumes of Modified Thoracoabdominal Perichondrial Approach (M-TAPA) in patients undergoing laparoscopic sleeve gastrectomy to determine the optimal volume for effective pain control and reduced opioid use.

Detailed description

This prospective randomized controlled trial will include patients scheduled for elective laparoscopic sleeve gastrectomy at Menoufia University Hospitals following approval by the institutional ethics committee. Written informed consent will be obtained from all participants. Randomization and Grouping Participants will be randomized into three groups using dark closed envelopes. Each group will receive a different volume of local anesthetic for M-TAPA after induction before the surgical procedure: * Group A: 20 mL: 20 mL of 0.25% bupivacaine per side (40 mL total). * Group B: 30 mL: 20 mL of 0.25% bupivacaine + 10 ml normal saline solution per side (60 mL total) . * Group C: 40 mL: 20 mL of 0.25% bupivacaine + 20 ml normal saline solution per side (80 mL total) . Sample size: 60 subjects Intervention All patients will receive standard general anesthesia, followed by bilateral ultrasound-guided M-TAPA. Monitoring Standard monitoring with electrocardiography, non-invasive blood pressure, capnography, a multi-gas analyzer, and peripheral oxygen saturation will be performed on all patients in the operating room (BIS, muscle relaxation, and TOF). Anesthesia induction and endotracheal intubation will be performed intravenously using propofol 2 mg/kg, fentanyl 1-2 µg/kg, and atracurium 0.4-0.5 mg/kg. Anesthesia will be maintained with isoflurane. A qualified anesthesiologist administering the block in the anatomical plane of M-TAPA will be excluded from the data collection procedure and will not be informed of the precise volume of the solution used. Inclusion Criteria Patients will be eligible for the study if they meet the following criteria: 1\. Adults aged \> 20 years to 60 years. 2. Scheduled for elective laparoscopic sleeve gastrectomy. Exclusion Criteria Patients will be excluded from the study if any of the following conditions apply: 1. American Society of Anesthesiology (ASA) ASA \> class 2. 2. History of chronic pain or opioid use for more than 3 months before surgery. 3. Previous major abdominal surgery (which may affect M-TAPA efficacy). 4. Known hypersensitivity or allergy to local anesthetics (e.g., bupivacaine). 5. Coagulopathy or ongoing anticoagulant therapy that could increase bleeding risk. 6. Local infection at the injection site. 7. Neuromuscular disorders affecting pain perception. 8. Patient with mental or psychiatric disorders. M-TAPA Technique Following tracheal intubation and prior to the start of the surgical procedure, the transversus abdominis, internal oblique, and external oblique muscles will be visualized using Digital Ultrasonic Diagnostic Imaging System: Mindray Model (DP-15), 75-L 38EB linear probe in the sagittal plane at the costochondral angle. The probe will be positioned at the 10th costal margin and angled deeply at the costochondral angle to view the inferior surface of the costal cartilage at the midline. A 21-G, 80-mm block needle will be inserted in the cranial direction using the in-plane technique, advancing the needle tip towards the posterior aspect of the 10th costal cartilage. Care will be taken to ensure the needle tip does not cross the cranial edge of the 10th costal cartilage. Once properly positioned, 0.25% bupivacaine will be injected beneath the costal cartilage. The same process will be repeated for the other side. Measuring Outcomes * Primary: * Time to First Rescue Analgesia: * This is the key primary outcome. It measures the duration from the end of surgery until the administration of the first rescue analgesic. * A longer time to first rescue analgesia indicates prolonged postoperative pain relief and higher efficacy of the M-TAPA block. * Secondary: * During surgery, the patients' vital signs (heart rate, blood pressure) will be measured to assess the effectiveness of the M-TAPA block in controlling pain without causing significant hemodynamic instability. After completion of the surgical procedure \& reversing the muscle relaxants and extubated, patients will be transferred to the postanesthetic care unit (PACU) for 30 minutes after the block, patients will be discharged to ward for first 24 h. Assessment: 1. Intraoperative Assessment: • Hemodynamic Monitoring: o Continuous monitoring of heart rate, blood pressure, and time interval of recovery throughout the surgery to assess the physiological response to pain. • Intraoperative Fentanyl consumption: (50 ml of Fentanyl \& be repeated) o The need for additional intraoperative analgesics will be recorded, including any increase in anesthetic requirements due to inadequate analgesia from the M-TAPA block With 20% elevation in hemodynamic or increase anesthetic requirements to achieve satisfactory BIS. 2. Postoperative Assessment: * Time to First Rescue for Analgesia: The interval between initial pain relief treatment and the need for an additional dose to maintain pain control, indicating the duration of analgesic effectiveness. * Pain Intensity Measurement (VAS Score): . Pain will be assessed using the Visual Analog Scale (VAS) at specific intervals after surgery, where: . VAS 0 = No Pain, and VAS 10 = Worst Possible Pain. . The overall VAS score will be calculated as the mean of all recorded VAS scores over the 24-hour postoperative period. . Patients reporting VAS ≥ 4 will receive Nalbuphine (3 mg IV) as rescue analgesia. * Total Analgesic Consumption: The total amount of analgesics (nalbuphine in mg) administered over 24 hours postoperatively will be recorded. • Hemodynamic Changes (Postoperative): Vital signs such as heart rate and blood pressure will be monitored regularly to detect any hemodynamic changes related to pain or analgesic administration. • Adverse Events or Side Effects: Any side effects of the analgesia (e.g., nausea, vomiting, respiratory depression) or adverse reactions to the M-TAPA block or analgesics will be recorded during the 24-hour postoperative period.

Conditions

• Time

Interventions

Type	Name	Description
PROCEDURE	Modified Thoracoabdominal Nerve Block through perichondrial approach (M-TAPA)	Following tracheal intubation and prior to the start of the surgical procedure, the transversus abdominis, internal oblique, and external oblique muscles will be visualized using Digital Ultrasonic Diagnostic Imaging System: Mindray Model (DP-15), 75-L 38EB linear probe in the sagittal plane at the costochondral angle. The probe will be positioned at the 10th costal margin and angled deeply at the costochondral angle to view the inferior surface of the costal cartilage at the midline. A 21-G, 80-mm block needle will be inserted in the cranial direction using the in-plane technique, advancing the needle tip towards the posterior aspect of the 10th costal cartilage. Care will be taken to ensure the needle tip does not cross the cranial edge of the 10th costal cartilage. Once properly positioned, 0.25% bupivacaine will be injected beneath the costal cartilage. The same process will be repeated for the other groups.

Timeline

• Start date: 2025-05-18
• Primary completion: 2026-05-18
• Completion: 2026-05-18
• First posted: 2026-04-03
• Last updated: 2026-04-03

Locations

1 site across 1 country: Egypt