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

ConditionTime
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-60
SponsorMenoufia University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Adults aged > 20 years to 60 years.

Scheduled for elective laparoscopic sleeve gastrectomy.

Disqualifiers

American Society of Anesthesiology (ASA) ASA > class 2.

History of chronic pain or opioid use for more than 3 months before surgery.

Previous major abdominal surgery (which may affect M-TAPA efficacy).

Known hypersensitivity or allergy to local anesthetics (e.g., bupivacaine).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Modified Thoracoabdominal Nerve Block through perichondrial approach (M-TAPA)

    Procedure/Surgery

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: group AActive comparator 1 intervention
Group B: group BExperimental treatment 1 intervention
Group C: group cExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
first 24 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

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