Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients
Recruiting · NCT06884852 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Erector spinae plane block (ESPB)Thoracic epidural block
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed.
- National Cancer Institute - Cairo, Egypt