Comparing two pain management techniques for breast cancer surgery

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

This study is testing whether a new pain management technique called erector spinae plane block can help people recovering from breast cancer surgery feel less pain and use fewer opioids compared to the traditional epidural method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 44 (estimated)
• Ages: 18 Years to 65 Years
• Sex: Female
• Sponsor: National Cancer Institute, Egypt (Academic / other)
• Locations: 1 site (Cairo)
• Trial ID: NCT06884852 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the effectiveness of multilevel erector spinae plane block (ESPB) compared to thoracic epidural analgesia in managing postoperative pain for patients undergoing modified radical mastectomy. It will assess various outcomes including the duration of pain relief, opioid consumption, and overall quality of life over a six-month period. The study focuses on minimizing complications associated with traditional pain management methods while providing effective analgesia. By utilizing ultrasound guidance, the ESPB technique is expected to offer a safer alternative for pain control.

Who should consider this trial

Good fit: Ideal candidates are female patients aged 18 to 65 who are undergoing modified radical mastectomy and have a physical status classified as ASA II or III.

Not a fit: Patients with contraindications to regional anesthesia, chronic pain history, or severe comorbidities such as advanced chronic renal disease or decompensated cirrhosis may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for breast cancer patients, reducing reliance on narcotics and their associated side effects.

How similar studies have performed: Previous studies have shown promising results with erector spinae plane blocks in postoperative pain management, indicating that this approach may be effective.

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.

Where this trial is running

Cairo

• National Cancer Institute — Cairo, Egypt (Recruiting)

Study contacts

• Study coordinator: Ahmed El Abdelaal, Master

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