Comparing two pain relief methods after breast surgery
Ultrasound-Guided Modified Pectoral Plane (PECS II) Block Versus Midpoint Transverse Process to Pleura (MTP) Block for Postoperative Analgesia of Modified Radical Mastectomy
This study is trying to see which of two pain relief methods works better for women after breast surgery to help them feel less pain and recover more comfortably.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 88 (estimated) |
| Ages | 40 Years to 65 Years |
| Sex | Female |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Cairo) |
| Trial ID | NCT06187909 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two different regional anesthesia techniques, the modified pectoral plane block (PECS II) and the midpoint transverse process to pleura block (MTP), for managing postoperative pain in women undergoing modified radical mastectomy (MRM). The study will assess pain levels during the first 24 hours after surgery using the Visual Analogue Scale. By evaluating these two methods, the research seeks to identify which technique provides better analgesia and potentially improves recovery outcomes for patients. The study is particularly focused on reducing the risk of chronic pain development following breast surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are female patients aged 40 to 65 scheduled for modified radical mastectomy.
Not a fit: Patients outside the age range of 40 to 65, those with contraindications to regional anesthesia, or those with severe medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for women undergoing breast surgery, enhancing recovery and reducing healthcare costs.
How similar studies have performed: Previous studies have shown promising results with similar regional anesthesia techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Female patients scheduled for MRM. 2. Age eligible ≥ 40 \& ≤ 65 yrs. 3. Patients with American Society of Anesthesiologists (ASA) physical status I, II who will be scheduled for MRM surgery. Exclusion Criteria: 1. Age \< 40 \& \> 65 years old. 2. Declining to give written informed consent. 3. History of allergy to the medications used in the study. 4. Contraindication to regional anesthesia (including coagulopathy (platelet count ≤ 80,000, INR ≥ 1.5) and local infection). 5. Severe hepatic impairment (INR ≥ 1.5, Bilirubin ≥ 2, Albumin ≤ 2). 6. Renal dysfunction \[Glomerular filtration rate \< 50ml/min calculated by Modification of diet in renal disease equation for GFR estimation\]. 7. Psychiatric disorder. 8. Pregnancy. 9. Patient with history of thoracic spine surgery.
Where this trial is running
Cairo
- Ain Shams University — Cairo, Egypt (Recruiting)
Study contacts
- Principal investigator: Diaaeldein M. Haiba, MD — Faculty of Medicine, Ain Shams University
- Study coordinator: Diaaeldein M. Haiba, MD
- Email: diaaeldein@med.asu.edu.eg
- Phone: 01006516286
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.