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

Launched by NATIONAL CANCER INSTITUTE, EGYPT · Mar 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different methods of pain relief for women undergoing a specific type of breast surgery called a modified radical mastectomy. The researchers want to compare the effectiveness of a technique called the erector spinae plane block (ESPB) with thoracic epidural analgesia, which is another way to manage pain. The goal is to see which method helps reduce pain after surgery, how much pain medication participants need, and how their quality of life is affected over the next six months.

To participate in this trial, women aged 18 to 65 who are having a modified radical mastectomy may be eligible, as long as they meet certain health criteria. For instance, they should have a body mass index (BMI) between 20 and 35 and be in good overall health, without severe medical conditions that could complicate surgery or pain management. If someone is interested in joining the study, they can expect to receive one of the two pain relief techniques and be monitored for their pain levels and recovery in the months following their surgery. This research could help improve pain management options for future breast cancer patients.

Gender

FEMALE

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.