About this trial
This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Intertransverse Process Block (ITPB) and the Subcostal External Oblique Intercostal Plane Block (EOIPB) in patients undergoing laparoscopic sleeve gastrectomy. 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 volunteersQualifiers
Patients aged 18-65 years
ASA physical status I-III
Scheduled for elective laparoscopic sleeve gastrectomy
Body mass index (BMI) >35 kg/m²
Disqualifiers
Refusal to participate
Allergy to local anesthetics
Infection at the injection site
Coagulopathy or ongoing anticoagulant therapy
Trial design
Parallel
Treatments tested in this trial
Intertransverse Process Block
Procedure/SurgeryUltrasound System, Model DC-T6) 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 mL 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.
External Oblique Intercostal Plane Block
Procedure/SurgeryAfter skin disinfection with chlorhexidine, the skin and subcutaneous tissues will be anesthetized using 2-4 mL of 1% lidocaine. A linear ultrasound probe will be positioned in a sagittal orientation along the midaxillary line at the level of the sixth rib. Anatomical landmarks, including the external oblique muscle, intercostal muscles, and ribs will be identified. Using an in-plane approach, a 21G 0.8×100 mm echogenic insulated needle will be inserted into the fascial plane between the external oblique muscle and the intercostal muscles. 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Total opioid consumption via patient-controlled analgesia (PCA)
Requirement for rescue analgesia
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.
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.
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: