Comparing two ultrasound-guided pain relief techniques after breast surgery
Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia in Modified Radical Mastectomy
This study is testing two different ultrasound-guided pain relief techniques to see which one helps women feel less pain after breast surgery while using fewer opioids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 21 Years to 64 Years |
| Sex | All |
| Sponsor | Zagazig University Government |
| Locations | 1 site (Zagazig) |
| Trial ID | NCT04531215 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two ultrasound-guided regional anesthesia techniques, the Retrolaminar Block (RLB) and the Erector Spinae Plane Block (ESPB), for providing postoperative analgesia in women undergoing modified radical mastectomy. The study aims to minimize opioid consumption and associated side effects by evaluating the safety and efficacy of these newer techniques compared to traditional methods. A total of 46 patients will be enrolled, with each technique being administered to 23 participants, and outcomes will be measured based on pain relief and complications. The trial seeks to provide a safer and more effective alternative for managing postoperative pain.
Who should consider this trial
Good fit: Ideal candidates are women aged 21-64 undergoing elective unilateral modified radical mastectomy with a BMI of 25-35.
Not a fit: Patients with coagulation disorders, chronic pain, or those who are pregnant or lactating may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing breast surgery, reducing reliance on opioids.
How similar studies have performed: Other studies have shown promising results with similar ultrasound-guided regional anesthesia techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient acceptance. * 21 - 64 years of age. * American Society of Anesthesiologist physical status class I,II. * Body Mass Index 25-35 kg/m2. * Female patient undergoing elective unilateral modified radical mastectomy under general anesthesia. Exclusion Criteria: * Coagulation disorders or anticoagulant therapy. * Known allergy to study drugs (Bupivacaine, Fentanyl) * Infection at the injection site. * Patients having chronic pain or on pain treatment. * Advanced renal, respiratory, hepatic or cardiovascular disorders. * Uncooperative patients. * Duration of surgery \> 3hours. * Pregnant or lactating females. * Metastasis.
Where this trial is running
Zagazig
- Zagazig University, Faculty of medicine — Zagazig, Egypt (Recruiting)
Study contacts
- Study coordinator: Alshaimaa Kamel, M.D
- Email: AlshaimaaKamel80@yahoo.com
- Phone: 01005593169
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.