Clinical trial · Interventional
Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients
NCT06884852CI-TRIAL-00089968recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Patients | — | UNRESOLVED | — |
| Multilevel Erector Spinae Plane Block | — | UNRESOLVED | — |
| Pain Syndrome | — | UNRESOLVED | — |
| Post Mastectomy | — | UNRESOLVED | — |
| Thoracic Epidural Analgesia | — | UNRESOLVED | — |
| Ultrasound | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Erector spinae plane block (ESPB) | Drug | — | UNRESOLVED |
| Thoracic epidural block | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Erector spinae plane block (ESPB)
- description
- Erector spinae plane block (ESPB) using multilevel injections of bupivacaine 0.25%. We injected 15ml at the level of T2 and 15ml at the level of T5.
- interventionNames
- Drug: Erector spinae plane block (ESPB)
- type
- EXPERIMENTAL
- label
- Thoracic epidural block
- description
- 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.
- interventionNames
- Drug: Thoracic epidural block
Primary outcomes (1)
- measure
- The average duration of analgesia
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.