Rhomboid Intercostal Block vs Erector Spinae Block

NCT ID: NCT07040618

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2026-08-01

Brief Summary

This randomized trial compares rhomboid intercostal block (RIB) and erector spinae plane block (ESPB) for postoperative pain control in lung cancer patients undergoing thoracotomy. Sixty patients will be assessed for 24-hour morphine consumption, pain scores, hemodynamics, recovery time, satisfaction, and side effects. The study aims to identify the more effective technique for enhancing recovery and minimizing opioid use.

Detailed Description

This randomized clinical trial aims to evaluate the analgesic efficacy of two ultrasound-guided regional anesthesia techniques-Rhomboid Intercostal Block (RIB) and Erector Spinae Plane Block (ESPB)-in female lung cancer patients undergoing thoracotomy at the National Cancer Institute, Cairo University. Thoracotomy is known for causing severe postoperative pain, which, if not effectively managed, can lead to chronic pain and impaired pulmonary function. Traditional techniques like thoracic epidural or paravertebral blocks, while effective, have limitations due to technical complexity and potential complications. Recently, interfascial plane blocks such as ESPB have shown promise for thoracic analgesia, and RIB has emerged as a technique potentially offering superior lateral thoracic wall coverage.

Sixty patients will be randomly assigned to receive either RIB or ESPB 30-45 minutes before surgery. The primary outcome is 24-hour postoperative morphine consumption. Secondary outcomes include visual analog scale (VAS) pain scores, hemodynamic stability, time to first analgesic request, recovery duration, patient satisfaction, and incidence of nausea and vomiting.

General anesthesia will be standardized across both groups. Data will be analyzed using appropriate statistical tests, and ethical approval will be obtained prior to patient enrollment. This study supports multimodal analgesia and aims to inform clinical practice in pain management after oncologic thoracic surgery.

Conditions

Lung Cancer

Study Design

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

Study Groups

Ultrasound-guided Rhomboid Intercostal Block

Patients in this group will receive a rhomboid intercostal block with 20-25 mL of 0.25% bupivacaine injected between the rhomboid major and intercostal muscles under ultrasound guidance 30-45 minutes before surgery.

Group Type: EXPERIMENTAL

Ultrasound-guided Rhomboid Intercostal Block

Intervention Type: PROCEDURE

This intervention involves an ultrasound-guided injection of 20-25 mL of 0.25% bupivacaine into the fascial plane between the rhomboid major and intercostal muscles. The patient is positioned laterally, and the block is performed at the T5-T6 level using a high-frequency linear ultrasound probe. The goal is to anesthetize the lateral cutaneous branches of the intercostal nerves to provide postoperative thoracic analgesia.

Ultrasound-guided Erector Spinae Plane Block

Patients in this group will receive an erector spinae plane block with 20-25 mL of 0.25% bupivacaine injected deep to the erector spinae muscle at the T4-T5 level under ultrasound guidance 30-45 minutes before surgery.

Group Type: ACTIVE_COMPARATOR

Ultrasound-guided Erector Spinae Plane Block

Intervention Type: PROCEDURE

This intervention consists of an ultrasound-guided injection of 20-25 mL of 0.25% bupivacaine into the plane deep to the erector spinae muscle at the T4-T5 transverse process level. The patient is positioned sitting or in lateral decubitus, and the procedure uses a curved or linear ultrasound probe. This block targets the dorsal and ventral rami of thoracic spinal nerves to manage postoperative pain after thoracotomy.

Interventions

Ultrasound-guided Rhomboid Intercostal Block

This intervention involves an ultrasound-guided injection of 20-25 mL of 0.25% bupivacaine into the fascial plane between the rhomboid major and intercostal muscles. The patient is positioned laterally, and the block is performed at the T5-T6 level using a high-frequency linear ultrasound probe. The goal is to anesthetize the lateral cutaneous branches of the intercostal nerves to provide postoperative thoracic analgesia.

Intervention Type: PROCEDURE

Ultrasound-guided Erector Spinae Plane Block

This intervention consists of an ultrasound-guided injection of 20-25 mL of 0.25% bupivacaine into the plane deep to the erector spinae muscle at the T4-T5 transverse process level. The patient is positioned sitting or in lateral decubitus, and the procedure uses a curved or linear ultrasound probe. This block targets the dorsal and ventral rami of thoracic spinal nerves to manage postoperative pain after thoracotomy.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients undergoing thoracotomy for lung cancer

Age ≥ 18 years and ≤ 65 years

ASA physical status II or III

Body Mass Index (BMI) > 20 kg/m² and < 35 kg/m²

Willing and able to provide informed consent

Exclusion Criteria

Patient refusal

ASA physical status IV

Age < 18 years or > 65 years

BMI < 20 kg/m² or > 35 kg/m²

Known allergy or contraindication to local anesthetics or opioids used in the study

History of chronic pain or psychological disorders

Contraindications to regional anesthesia (e.g., local infection, coagulopathy, pre-existing peripheral neuropathy)

Severe respiratory, cardiac, hepatic, or renal disease

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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Sayed Mahmoud Abed

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sayed M Abed, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Anesthesia and Pain Management, National Cancer Institute -- Cairo University

Locations

National Cancer Institute - Cairo University

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Sayed M Abed, MD

Role: CONTACT

sayed.abed@nci.cu.edu.eg

+20 122 680 6532

Related Links

https://pubmed.ncbi.nlm.nih.gov/11394926/

The morbidity, time course and predictive factors for persistent post-thoracotomy pain

https://pubmed.ncbi.nlm.nih.gov/19854794/

In patients undergoing thoracic surgery is paravertebral block as effective as epidural analgesia for pain management?

Other Identifiers

NCI-CAIRO-RIb-ESPB-2025

Identifier Type: -

Identifier Source: org_study_id