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

NCT ID: NCT06884852

Last Updated: 2025-05-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-03-01

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.

Detailed Description

Breast cancer is the most common malignancy among females. Modified Radical Mastectomy (MRM) is the principal surgical treatment for breast cancer. The standard mode of anesthesia is general anesthesia, in addition to regional blocks for effective postoperative pain control.

Pain is usually managed by narcotics, which have many side effects, including prolonged sedation, increasing incidence of pain recurrence, respiratory depression, nausea & vomiting and paralytic ileus. All requiring close monitoring and in some occasions Intensive Care Unit (ICU) admission. Thoracic epidural and paravertebral blocks are the gold standard techniques. However, both techniques may lead to some serious complications including spinal cord injury, pneumothorax, incompatibility with pre-existing anticoagulation or antiplatelet therapy and hemodynamic instability.

Recently, multiple regional techniques have been used for postoperative thoracic pain control, including that caused by modified radical mastectomy. Interfascial plane blocks are currently the hot topic in management of postoperative pain. One of these blocks is erector spinae plane block (ESPB). It is an interfacial Para spinal plane block that is simple, safe, effective and associated with fewer complications in comparison to the gold standard techniques.

Conditions

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

Study Design

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

Study Groups

Erector spinae plane block (ESPB)

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.

Group Type: EXPERIMENTAL

Erector spinae plane block (ESPB)

Intervention Type: 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.

Thoracic epidural block

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.

Group Type: EXPERIMENTAL

Thoracic epidural block

Intervention Type: 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.

Interventions

Erector spinae plane block (ESPB)

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.

Intervention Type: DRUG

Thoracic epidural block

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.

Intervention Type: DRUG

Other Intervention Names

Bupivacaine 0.25%; Bupivacaine 0.25%

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

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

Sponsors

National Cancer Institute, Egypt

OTHER

Sponsor Role: lead

Responsible Party

Dr Ahmed elsayeh

Assistant Lecturer of Anesthesiology, Surgical Intensive Care Unit and Pain Medicine, National Cancer Institute ,Cairo University, Egypt

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Cancer Institute

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Ahmed El Abdelaal, Master

Role: CONTACT

drahmedsayeh9915@gmail.com

00201097900275

Facility Contacts

Ahmed El Abdelaal, Master

Role: primary

drahmedsayeh9915@gmail.com

00201097900275

Other Identifiers

AP2405-201-046-193

Identifier Type: -

Identifier Source: org_study_id