Actively Recruiting
Ultrasound-guided Multilevel Erector Spinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome in Breast Cancer Patients
Led by National Cancer Institute, Egypt · Updated on 2025-05-21
44
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare two types of pain relief techniques used during and after surgery for breast cancer patients undergoing modified radical mastectomy. It focuses on evaluating the duration of pain relief, the amount of opioid medication needed after surgery, the effect on pain medication used during surgery, pain levels, and quality of life over six months. The study is conducted by the National Cancer Institute, Egypt, to explore safer and effective pain management options. The study compares the erector spinae plane block (ESPB) with the thoracic epidural block. The ESPB involves ultrasound-guided injections of bupivacaine at two levels of the spine, while the thoracic epidural uses a bolus and repeated doses of bupivacaine near the spinal cord. Both methods are regional anesthesia techniques given during surgery, aiming to control pain with fewer side effects and complications than traditional narcotics. Participants will be monitored for pain relief duration, opioid consumption, heart rate, blood pressure, nausea, vomiting, and any complications related to the anesthesia techniques. Pain levels and patient satisfaction will be assessed within 24 hours after surgery, and long-term effects like postmastectomy pain syndrome and block-related complications will be evaluated over six months. The study uses random assignment to each treatment group and measures outcomes to understand which method provides better pain control and recovery experience.
CONDITIONS
Brief Title
Ultrasound-guided Multilevel Erectorspinae Plane Block Versus Thoracic Epidural Analgesia for Prevention of Post Mastectomy Pain Syndrome for Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 to 65 years
- Scheduled for modified radical mastectomy surgery
- Physical status ASA II or III
- Body mass index (BMI) between 20 and 35 kg/m2
You will not qualify if you...
- Patient refusal to participate
- Allergy or contraindication to local anesthetics or opioids used in the study
- History of psychological disorders
- History of chronic pain
- Contraindications to regional anesthesia such as sepsis, peripheral neuropathies, or coagulopathy
- Advanced chronic kidney disease with severe reduced filtration rate (GFR < 30 ml/min)
- Decompensated liver cirrhosis with serious symptoms
- Severe heart disease classified as NYHA class III or IV
- Severe lung disease with low oxygen saturation, high respiratory rate, or poor lung function
- Pregnancy
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Surgery day and immediate perioperative period
Participants receive either an erector spinae plane block or thoracic epidural block during their modified radical mastectomy surgery to manage postoperative pain.
1 visit (in-person) on the day of surgery
Duration - 24 hours postoperatively with additional monitoring up to 6 months
Participants are monitored for pain control, medication use, and any complications related to the blocks for 24 hours postoperatively, with additional assessments for long-term pain outcomes up to 6 months after surgery.
Regular assessments during the first 24 hours and follow-up visits up to 6 months
Trial Site Locations
Total: 1 location
1
National Cancer Institute
Cairo, Egypt, 11796
Actively Recruiting
Research Team
A
Ahmed El Abdelaal, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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