Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients

NCT06884852 | Recruiting

• 1 other identifier: AP2405-201-046-193
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to compare the analgesic efficacy of multilevel erector spinae plane block (ESPB) vs thoracic epidural in modified radical mastectomy (MRM) regarding duration of analgesia, postoperative opioid consumption, effect on intraoperative fentanyl consumption, postoperative numerical pain rating scale and quality of life for the next 6 months.

Conditions

Ultrasound; Multilevel Erector Spinae Plane Block; Thoracic Epidural Analgesia; Post Mastectomy; Pain Syndrome; Breast Cancer Patients

Outcome Measures

Primary Outcomes (1)

• The average duration of analgesia

  The average duration of analgesia will be recorded from the end of surgery till the first dose of morphine administrated.

  24 hours postoperatively

Secondary Outcomes (10)

• The total amount of morphine

  24 hours postoperatively

• Incidence of postmastectomy pain syndrome

  6 months postoperatively

• The total amount of fentanyl

  Intraoperatively

• Heart rate (HR)

  24 hours Postoperatively

• Mean arterial blood pressure (MAP)

  24 hours Postoperatively

Study Arms (2)

Erector spinae plane block (ESPB)

EXPERIMENTAL

Erector spinae plane block (ESPB) using multilevel injections of bupivacaine 0.25%. We injected 15ml at the level of T2 and 15ml at the level of T5.

Drug: Erector spinae plane block (ESPB)

Thoracic epidural block

EXPERIMENTAL

Thoracic epidural block at level of T5 -T6 using 10 ml of bupivacaine 0.25% as a bolus followed by 5 ml bupivacaine 0.25% every 1-2 hours depending on the duration of surgery and the response of the patient.

Drug: Thoracic epidural block

Interventions

Erector spinae plane block (ESPB) DRUG

Erector spinae plane block (ESPB) using multilevel injections of bupivacaine 0.25%. We will inject 15ml at the level of T2 and 15ml at the level of T5.

Also known as: Bupivacaine 0.25%

Erector spinae plane block (ESPB)

Thoracic epidural block DRUG

Thoracic epidural block at level of T5 -T6 using 10 ml of bupivacaine 0.25% as a bolus followed by 5 ml bupivacaine 0.25% every 1-2 hours depending on the duration of surgery and the response of the patient.

Also known as: Bupivacaine 0.25%

Thoracic epidural block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Female patients
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients age ≥ 18 years and ≤ 65 Years.
• Type of surgery; Modified Radical Mastectomy (MRM)
• Physical status ASA II, III.
• Body mass index (BMI): \> 20 kg/m2 and \< 35 kg/m2.

You may not qualify if:

• Patient refusal.
• Allergy or a contraindication to the drug used in the study, e.g. local anesthetics, opioids.
• History of psychological disorders.
• History of chronic pain.
• Contraindication to regional anesthesia e.g. sepsis, peripheral neuropathies and coagulopathy.
• Advanced chronic renal disease, which is defined as a chronic kidney disease (CKD) in which there is a severe reduction in glomerular filtration rate (GFR \< 30 ml/min) and includes stages 4 and 5 of the CKD classification.
• Decompensated cirrhosis, which is defined as an acute deterioration in liver function in a patient with cirrhosis and is characterized by jaundice, ascites, hepatic encephalopathy, hepatorenal syndrome, or variceal hemorrhage.
• Severe heart disease which is defined as NYHA class iii (moderate symptoms with less than normal activity, marked limitation of function status) or NYHA class IV (severe symptoms with features of heart failure with minimal activity or at rest and severe limitation of functional status)
• Severe lung disease which includes oxygen saturation of blood less than 92%, RR more than 20, FEV1/FVC ratio less than 60%.
• Pregnancy.

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

RECRUITING

MeSH Terms

Conditions

Somatoform Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Ahmed El Abdelaal, Master

CONTACT

00201097900275; drahmedsayeh9915@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care Unit and Pain Medicine, National Cancer Institute ,Cairo University, Egypt

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: March 20, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)