Ultrasound-Guided RSCTL vs EOIP Block for Analgesia in Sleeve Gastrectomy

NCT ID: NCT07311525

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-01
• Study Completion Date: 2027-02-01

Brief Summary

The aim of this study is to compare the effect of ultrasound-guided retro-SCTL space block and EOI block on opioid consumption within 24 hours after LSG.

Detailed Description

Obesity is ranked as the 5th cause of preventable death and is associated with certain diseases, e.g., type 2 diabetes mellitus, hypertension, ischemic heart disease, hyperlipidemia, and sleep apnea. Egypt has the world's 18th highest obesity prevalence, according to the World Health Organization (WHO). Bariatric surgery is the most effective treatment for weight loss, reducing obesity-related comorbidities and mortality. This surgery has been shown to improve quality of life. Bariatric surgery is now universally performed laparoscopically and is the most performed elective surgery in patients with morbid obesity. Laparoscopic sleeve gastrectomy (LSG) has been shown to be related to lower complication rates, shorter hospital stays, and earlier re-engagement in normal activities than open procedures. However, postoperative pain is common. Pain often originates from port sites in the abdominal wall. As LSG requires removal of the relatively large resected gastric segment, this often requires enlargement of the trocar site and the fascial incision, which adds to the pain. Postoperative pain may be significant and has a negative impact on recovery, respiration, hemodynamics, mentation, ambulation, bowel function, and length of hospital stay. Also, opioid analgesia in obese patients is associated with serious adverse effects such as hypopnoea, hypoxaemia, drowsiness, ileus, vomiting, delayed ambulation, and mortality. These complications are compounded by pre-existing obstructive sleep apnea (OSA), cardiorespiratory insufficiency, psychiatric disorders, and chronic opioid use, which may be present in obese patients. Although epidural anesthesia is effective in pain control, positioning is extremely difficult in obese patients. Some regional anesthesia techniques such as transverse abdominis plane (TAP) block, quadratus lumborum (QL) block, and erector spinae plane (ESP) block may be used as a part of a multimodal analgesic regimen to reduce opioid consumption

. However, technical challenges such as difficulty in identifying the structures and limitations in needle movement may be experienced due to the deep anatomical location of structures when performing these blocks in patients with obesity.

Intertransverse process block (ITPB) is a paraspinal thoracic nerve block technique where the local anesthetic (LA) is injected into the thoracic "intertransverse tissue complex", behind the superior costotransverse ligament (SCTL). The retro superior costotransverse ligament space (retro-SCTL space) block is a novel ITPB, targeting the fat-filled space in the retro-SCTL space. ITPB may be technically simpler and safer to avoid pleural puncture than a thoracic paravertebral block (TPVB) since it does not require direct needle access to the thoracic paravertebral space.

External oblique intercostal plane (EOI) block, a nerve block , has an efficacy range of T6-10. EOI block is one of the novel interfascial plane blocks. EOI block can be performed as part of multimodal analgesia for upper abdominal surgeries. In addition, easy visualization of the application area with ultrasound guidance is an advantage for obese patients. While both retro-SCTL and EOI blocks are emerging techniques, a direct comparison of their analgesic efficacy and opioid-sparing effects in the context of LSG has not yet been performed. This study aims to directly address this gap.

Conditions

Patient Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

retro-SCTL block

Participants in the (group retro-SCTL) will receive ultrasound-guided retro-SCTL space block after intubation. Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected. The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side.

Group Type: ACTIVE_COMPARATOR

ultrasound-guided Retro superior costotransverse ligament space block

Intervention Type: PROCEDURE

Participants will receive ultrasound-guided Retro superior costotransverse ligament space block after intubation. Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected. The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side.

EOI block

Participants in the (group EOI) will receive ultrasound-guided EOI block after intubation. Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected. The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side.

Group Type: ACTIVE_COMPARATOR

ultrasound-guided External Oblique Intercostal Plane Block

Intervention Type: PROCEDURE

Participants will receive ultrasound-guided External Oblique Intercostal Plane Block after intubation.Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected. The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side.

Interventions

ultrasound-guided Retro superior costotransverse ligament space block

Participants will receive ultrasound-guided Retro superior costotransverse ligament space block after intubation. Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected. The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side.

Intervention Type: PROCEDURE

ultrasound-guided External Oblique Intercostal Plane Block

Participants will receive ultrasound-guided External Oblique Intercostal Plane Block after intubation.Following hydrodissection with 2 ml of 0.9% saline to confirm the correct needle tip position, 20 ml 0.25% bupivacaine was injected. The same procedure was then repeated with 20 ml 0.25% bupivacaine on the contralateral side.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients aged between 18 to 65 years
• Both genders
• American Society of Anesthesiologists (ASA) physical status I-II
• Body mass index (BMI) > 40 kg m-2,

Exclusion Criteria

• Obesity secondary to an endocrine disorder
• known allergic diathesis to any drugs used in the study
• Presence of serious systemic illness (e.g., severe cardiac, pulmonary, renal, or hepatic dysfunction),
• Coagulation dysfunction
• Pre-existing psychological disorders
• Current use of analgesic or psychotropic medications
• Infection at a potential injection site
• Ahistory of chronic pain
• Conversion to laparotomy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Dina Mahmoud Fakhry

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Management

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dina M Fakhry, MD

Role: PRINCIPAL_INVESTIGATOR

Beni-Suef University

Locations

Beni-Suef University hospital

Banī Suwayf, Beni Suweif Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Dina M Fakhry, MD

Role: CONTACT

dina_fakhry_91@yahoo.com

00201289998680

Facility Contacts

Dina M Fakhry, MD

Role: primary

drdina.mahmoud@med.bsu.edu.eg

01289998680

Other Identifiers

FMBSUREC/05102025/Fakhry

Identifier Type: -

Identifier Source: org_study_id