Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy

Comparison of Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy: A Randomized Controlled Trial

This study aims to compare the costotransverse foramen block with erector spinae plane block in modified radical mastectomy.

Study Overview

• Status: Recruiting
• Conditions: Erector Spinae Plane Block; Modified Radical Mastectomy; Costotransverse Foramen Block
• Intervention / Treatment: Other: Costotransverse foramen block; Other: Erector spinae plane block

Detailed Description

Postoperative pain following modified radical mastectomy (MRM) is a considerable consequence, impacting the ipsilateral upper limbs, axillae, and thorax, resulting in diminished functional ability and substantial economic and societal repercussions.

Erector spinae plane block (ESPB), an interfascial block, minimizes nerve and vessel injury by allowing local anesthetics to diffuse across relevant spaces; it is technically simpler and has shown benefits in reducing postoperative analgesic use and pain scores.

A novel technique, the costotransverse foramen block (CTFB), is one type of Inter-transverse process (ITP) blocks. This technique entails the anterior dispersion of the local anesthetic injectate into the paravertebral region, affecting the thoracic nerve at the injection site and neighboring levels, while exhibiting negligible posterior diffusion of dye to the deep back muscles

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mai M Elrawas, MD; Phone Number: 00201222177242; Email: mai.elrawas@nci.cu.edu.eg

Study Locations

• Egypt
  • Cairo, Egypt, 12613
    • Recruiting
    • Cairo University
    • Contact: Mai M Elrawas, MD; Phone Number: 00201222177242; Email: mai.elrawas@nci.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult females > 18 years and ≤ 65 years old.
• American Society of Anesthesiologists (ASA) physical status П-III.
• Body mass index (BMI) 18-35 kg/m2.
• Scheduled for modified radical mastectomy.

Exclusion Criteria:

• Known allergy or hypersensitivity to local anesthetic agents.
• Active infection at the injection site (e.g., cellulitis, abscess).
• Coagulopathy or ongoing anticoagulant/antiplatelet therapy [International Normalized Ratio (INR) > 1.5 or platelet count < 100,000/µL].
• Severe respiratory, cardiac, hepatic, or renal disease.
• Morbid obesity.
• Severe cognitive impairment or uncooperative behavior that could interfere with block placement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CTFB Group; Patients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%.	Other: Costotransverse foramen block; Patients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%.
Experimental: ESPB Group; Patients will receive an ipsilateral ultrasound-guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.	Other: Erector spinae plane block; Patients will receive an ipsilateral ultrasound-guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total morphine consumption	If the numeric rating scale (NRS) is ≥ 4, an IV morphine dose (3 mg) will be provided Paracetamol 1 gm and ketorolac 30 mg will be administered every 8 hours postoperatively.	24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative fentanyl consumption	Intraoperative fentanyl consumption will be recorded.	Intraoperatively
Degree of pain	Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS score will be recorded in post-anesthesia care unit (PACU) then at 1, 6, 12, 18, 24, and 48 hours postoperatively.	48 hours postoperatively
Time to first request of rescue analgesia	Time to first request of rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.	24 hours postoperatively
Mean arterial pressure	Mean arterial pressure will be recorded immediately before induction of anesthesia, 15 min after performing the block incision and at 20-minute intervals intraoperatively, and then hourly till 4 hours postoperatively.	4 hours postoperatively
Heart rate	Heart rate will be recorded immediately before induction of anesthesia, 15 min after performing the block incision and at 20-minute intervals intraoperatively, and then hourly till 4 hours postoperatively.	4 hours postoperatively
Incidence of adverse effects	Incidence of adverse effects such as nausea, vomiting, hypotension, and bradycardia, pneumothorax, local anesthetic toxicity for up to 24 hours post-surgery will be documented.	24 hours postoperatively

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: January 17, 2026
• First Submitted That Met QC Criteria: January 17, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 24, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: AP2509-501-124-203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No