Comparing two pain management techniques for breast cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• National Cancer Institute
  Cairo, Egypt Recruiting

Study contacts

• Study coordinator: Ahmed El Abdelaal, Master
• Email: drahmedsayeh9915@gmail.com
• Phone: 00201097900275

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.