Intertransverse Process Block Versus M-TAPA Block After Laparoscopic Cholecystectomy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAntalya City Hospital

About this trial

This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Intertransverse Process Block (ITPB) and the Modified Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) in patients undergoing laparoscopic cholecystectomy. The primary outcome is the Visual Analog Scale (VAS) score within the first 24 hours after surgery. Secondary outcomes include total opioid consumption, requirement for rescue analgesia, block- related complications and adverse effects (hematoma, pneumothorax, local anesthetic systemic complications, vascular puncture, and infection), patient satisfaction assessed using a Likert scale, quality of recovery assessed using the QoR-15 questionnaire, and incidence of postoperative nausea and vomiting.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-65 years

ASA physical status I-III

Scheduled for elective laparoscopic sleeve gastrectomy

Body mass index (BMI) 18-35 kg/m²

Disqualifiers

Refusal to participate

Allergy to local anesthetics

Infection at the injection site

Coagulopathy or ongoing anticoagulant therapy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intertransverse Process Block

    Procedure/Surgery

    A linear ultrasound probe will be positioned along the medial border of spinous processes level of the T7/T8 thoracic vertebrae.Anatomical landmarks, including the erector spinae muscle, transverse processes, and superior costotransverse ligament complex at the T7/T8 level, will be identified. Using an in-plane approach, a 21 G 0.8x100 mm echogenic insulated needle will be inserted through the erector spinae muscle toward the intertransverse tissue complex located between the superior costotransverse ligament and the transverse processes. Proper needle placement will be confirmed with the injection of 1-2 mmL isotonic saline demonstrating separation within the intertransverse plane. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.

  • M-TAPA Block

    Procedure/Surgery

    A linear ultrasound probe will be positioned obliquely along the costal margin at the level of the 10th costal cartilage. Anatomical landmarks, including the costal cartilage, rectus abdominis muscle, transversus abdominis muscle, and internal oblique muscle will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle will be inserted toward the perichondrial plane beneath the 10th costal cartilage under ultrasound guidance. Proper needle placement will be confirmed with the injection of 1-2 mL isotonic saline. Upon confirmation and negative aspiration, 20 mL of 0.25% bupivacaine hydrochloride will be administered on each side under ultrasound guidance.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Intertransverse Process BlockActive comparator 1 intervention
Group B: M-TAPA BlockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative pain intensity (VAS score)

Postoperative pain will be assessed using the visual analog scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores represent greater pain intensity.

Time frame
0, 1, 4, 8, 12, and 24 hours after surgery

Secondary outcomes

1

Total opioid consumption via patient-controlled analgesia (PCA)

Time frame
Within the first 24 hours postoperatively
2

Requirement for rescue analgesia

Time frame
Within the first 24 hours postoperatively
3

Potential Complications

Any complications associated with the block or the surgical procedure (e.g., hematoma, pneumothorax, local anesthetic systemic toxicity, vascular puncture, or infection) will be recorded.

Time frame
Within the first 24 hours postoperatively
4

Patient satisfaction

Patient satisfaction will be assessed using Likert scala (1 =very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, 5 = very satisfied). Higher scores indicate greater satisfaction.

Time frame
At 24 hours postoperatively

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: