RecruitingNot ApplicableNCT06884852

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

Sponsor

National Cancer Institute, Egypt

Enrollment

44 participants

Start Date

Mar 20, 2025

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

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 Criteria10

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.

Interventions

DRUGErector 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.

DRUGThoracic 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.