Comparison of Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- National Cancer Institute, Egypt
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Total morphine consumption
Overview
Brief Summary
This study aims to compare the costotransverse foramen block with erector spinae plane block in modified radical mastectomy.
Detailed Description
Postoperative pain following modified radical mastectomy (MRM) is a considerable consequence, impacting the ipsilateral upper limbs, axillae, and thorax, resulting in diminished functional ability and substantial economic and societal repercussions.
Erector spinae plane block (ESPB), an interfascial block, minimizes nerve and vessel injury by allowing local anesthetics to diffuse across relevant spaces; it is technically simpler and has shown benefits in reducing postoperative analgesic use and pain scores.
A novel technique, the costotransverse foramen block (CTFB), is one type of Inter-transverse process (ITP) blocks. This technique entails the anterior dispersion of the local anesthetic injectate into the paravertebral region, affecting the thoracic nerve at the injection site and neighboring levels, while exhibiting negligible posterior diffusion of dye to the deep back muscles
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult females \> 18 years and ≤ 65 years old.
- •American Society of Anesthesiologists (ASA) physical status П-III.
- •Body mass index (BMI) 18-35 kg/m
- •Scheduled for modified radical mastectomy.
Exclusion Criteria
- •Known allergy or hypersensitivity to local anesthetic agents.
- •Active infection at the injection site (e.g., cellulitis, abscess).
- •Coagulopathy or ongoing anticoagulant/antiplatelet therapy \[International Normalized Ratio (INR) \> 1.5 or platelet count \< 100,000/µL\].
- •Severe respiratory, cardiac, hepatic, or renal disease.
- •Morbid obesity.
- •Severe cognitive impairment or uncooperative behavior that could interfere with block placement.
Arms & Interventions
CTFB Group
Patients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%.
Intervention: Costotransverse foramen block (Other)
ESPB Group
Patients will receive an ipsilateral ultrasound-guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.
Intervention: Erector spinae plane block (Other)
Outcomes
Primary Outcomes
Total morphine consumption
Time Frame: 24 hours postoperatively
If the numeric rating scale (NRS) is ≥ 4, an IV morphine dose (3 mg) will be provided Paracetamol 1 gm and ketorolac 30 mg will be administered every 8 hours postoperatively.
Secondary Outcomes
- Degree of pain(48 hours postoperatively)
- Time to first request of rescue analgesia(24 hours postoperatively)
- Intraoperative fentanyl consumption(Intraoperatively)
- Mean arterial pressure(4 hours postoperatively)
- Heart rate(4 hours postoperatively)
- Incidence of adverse effects(24 hours postoperatively)
Investigators
Mai Mohamed El Rawas
Assistant professor of Anaesthesia, Intensive Care and Pain Management, National Cancer Institute, Cairo University Cairo University, Cairo, Egypt.
National Cancer Institute, Egypt