Intertransverse Process Block Versus Subcostal Transversus Abdominis Plane Block After Laparoscopic Sleeve Gastrectomy

NCT07591129 | Not Yet Recruiting

• 1 other identifier: ITP-Subcostal TAP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial aims to evaluate and compare the analgesic efficacy of the Intertransverse Process Block (ITPB) and the Subcostal Transversus Abdominis Plane Block (TAPB) 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.

Conditions

Subcostal Transverse Abdominis Plane Block; Sleeve Gastrectomy; Postoperative Pain; Regional Anaesthesia; Intertransverse Process Block

Keywords

ITP; TAP; PAİN; SLEEVE GASTRECTOMİ

Outcome Measures

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.

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

Secondary Outcomes (6)

• Total opioid consumption via patient-controlled analgesia (PCA)

  Within the first 24 hours postoperatively

• Requirement for rescue analgesia

  Within the first 24 hours postoperatively

• Potential Complications

  Within the first 24 hours postoperatively

• Patient satisfaction

  At 24 hours postoperatively

• Quality of recovery assessed using the QoR-15 questionnaire

  At 24 hours postoperatively

Study Arms (2)

Intertransverse Process Block (ITPB)

ACTIVE COMPARATOR

Procedure: Intertransverse Process Block

Subcostal Transversus Abdominis Plane Block (TAPB)

ACTIVE COMPARATOR

Procedure: The Subcostal Transversus Abdominis Plane Block (TAPB)

Interventions

Intertransverse Process Block PROCEDURE

Ultrasound 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.

Intertransverse Process Block (ITPB)

The Subcostal Transversus Abdominis Plane Block (TAPB) PROCEDURE

After 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 parallel to the lower costal margin. Anatomical landmarks, including the rectus abdominis muscle, posterior rectus sheath, and transversus abdominis muscle 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 posterior rectus sheath and the transversus abdominis muscle. 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.

Subcostal Transversus Abdominis Plane Block (TAPB)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18-65 years
• ASA physical status I-III
• Scheduled for elective laparoscopic sleeve gastrectomy
• Body mass index (BMI) \>35 kg/m²
• Ability to understand and use the patient-controlled analgesia (PCA) device
• Ability to provide written informed consent

You may not qualify if:

• Refusal to participate
• Allergy to local anesthetics
• Infection at the injection site
• Coagulopathy or ongoing anticoagulant therapy
• Chronic opioid use or opioid dependence
• Severe hepatic or renal insufficiency
• Pregnancy or breastfeeding
• Cognitive impairment or inability to communicate pain scores
• Body mass index (BMI) \>35 kg/m²

Sponsors & Collaborators

• Antalya City Hospital: lead

Study Sites (1)

Antalya Şehir Hastanesi

Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Mustafa KILIN, consultant in anesthesiology

CONTACT

+905464569218; mustafa.kilin90@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant in anesthesiology

Study Record Dates

• First Submitted: May 9, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): December 30, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): May 30, 2028
• Last Updated: May 15, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)