N/A
N=20
Comparing Post-operative Analgesia After (PECS II) Block and (ESPB) in Modified Radical Mastectomy
Anaesthesia
Bottom Line
View on ClinicalTrials.gov: NCT06714682 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit. — 0.4; 0.9 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Modified Pectoral Plane block group (Procedure); Erector spinae plane block group. (Procedure)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- Female
- Sponsor
- Ain Shams University
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Pain Severity Assessed by Visual Analogue Scale Immediately Postoperative on Admission to the Post Anesthesia Care Unit. |
0.4; 0.9 | — |
| SECONDARY Post-operative Pain Severity Assessed by Visual Analogue Scale at 2 Hours, 4 Hours, 8 Hours, 12 Hours, 18 Hours and 24 Hours Post-operatively. |
1.3; 1.9; 1.4; 3.1; 2.8; 3.8 | — |
Summary
The aim of this study is to compare the analgesic efficacies of the modified pectoral plane block (PECS II) and the erector spinae plane block (ESPB) after modified radical mastectomy surgery through assessment of post-operative pain severity by Visual Analogue Score at PACU as a primary outcome and at 2 hours, 4 hours, 8 hours, 12 hours, 18 hours and 24 hours post-operatively also by comparing time of first rescue analgesia and cumulative post-operative meperidine consumption in the first 24 hours as secondary outcomes.
Eligibility Criteria
Inclusion Criteria
- Female patients scheduled for MRM.
- Age eligible ≥ 40 & ≤ 65 yrs.
- Patients with American Society of Anesthesiologists (ASA) physical status I, II who will be scheduled for Modified Radical Mastectomy surgery.
Exclusion Criteria
- Age 65 years old.
- Declining to give written informed consent.
- History of allergy to the medications used in the study.
- Contraindication to regional anesthesia [including coagulopathy (platelet count ≤ 80,000, INR ≥ 1.5) and local infection].
- Severe hepatic impairment (INR ≥ 1.5, Bilirubin ≥ 2, Albumin ≤ 2).
- Renal dysfunction [GFR < 50 ml/min calculated by MDRD (Modification of diet in renal disease) equation for GFR estimation (Livio et al., 2008)].
- Psychiatric disorder.
- Pregnancy.
- Patient with history of thoracic spine surgery.
Data sourced from ClinicalTrials.gov (NCT06714682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.