NCT07040618

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable lung-cancer

Timeline
3mo left

Started Jul 2025

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Jul 2025Aug 2026

First Submitted

Initial submission to the registry

June 18, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 27, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

June 18, 2025

Last Update Submit

March 16, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 24-hour postoperative morphine consumption

    This outcome measures the total amount of morphine (in milligrams) administered to each patient within the first 24 hours after thoracotomy. Morphine will be given as rescue analgesia when the patient reports a visual analog scale (VAS) pain score of 4 or more. The cumulative dose will be recorded and compared between the Rhomboid Intercostal Block (RIB) and Erector Spinae Plane Block (ESPB) groups to evaluate the relative effectiveness of each regional anesthesia technique in managing postoperative pain.

    Within the first 24 hours postoperatively

Study Arms (2)

Ultrasound-guided Rhomboid Intercostal Block

EXPERIMENTAL

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.

Procedure: Ultrasound-guided Rhomboid Intercostal Block

Ultrasound-guided Erector Spinae Plane Block

ACTIVE COMPARATOR

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.

Procedure: Ultrasound-guided Erector Spinae Plane Block

Interventions

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 Rhomboid Intercostal 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.

Ultrasound-guided Erector Spinae Plane Block

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Institute - Cairo University

Cairo, Egypt

RECRUITING

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sayed M Abed, MD

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This is a parallel-group randomized controlled trial comparing the effectiveness of two ultrasound-guided regional anesthesia techniques-Rhomboid Intercostal Block (RIB) and Erector Spinae Plane Block (ESPB)-in managing postoperative pain in lung cancer patients undergoing thoracotomy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

June 18, 2025

First Posted

June 27, 2025

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared due to institutional policy and privacy concerns. The study involves sensitive patient data from a cancer population, and data sharing may pose risks to confidentiality despite de-identification efforts. Access will remain restricted to the research team at the National Cancer Institute, Cairo University, in accordance with ethical approval and informed consent protocols.

Locations