Status:
RECRUITING
Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients
Lead Sponsor:
National Cancer Institute, Egypt
Conditions:
Ultrasound
Multilevel Erector Spinae Plane Block
Eligibility:
FEMALE
18-65 years
Phase:
NA
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, po...
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 anesthesi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06884852
Start Date
March 20 2025
End Date
March 1 2026
Last Update
May 21 2025
Active Locations (1)
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1
National Cancer Institute
Cairo, Egypt, 11796