Cairo University
Cairo, 12613, Egypt
Location status: Recruiting
NCT Number: NCT07367568
This study aims to compare the costotransverse foramen block with erector spinae plane block in modified radical mastectomy.
Interested in participating?
Request Info18 year–65 year
Female
Interventional
Not applicable
Cairo, 12613, Egypt
Location status: Recruiting
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive an ipsilateral ultrasound-guided costotransverse foramen block with injection of 20 ml bupivacaine 0.25%.
Patients will receive an ipsilateral ultrasound-guided erector spinae plane block with injection of 20 ml bupivacaine 0.25%.
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.
Time frame: 48 hours postoperatively
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS score will be recorded in post-anesthesia care unit (PACU) then at 1, 6, 12, 18, 24, and 48 hours postoperatively.
Time frame: 24 hours postoperatively
Time to first request of rescue analgesia will be recorded from the end of surgery till first dose of morphine administrated.
Time frame: Intraoperatively
Intraoperative fentanyl consumption will be recorded.
Time frame: 4 hours postoperatively
Mean arterial pressure will be recorded immediately before induction of anesthesia, 15 min after performing the block incision and at 20-minute intervals intraoperatively, and then hourly till 4 hours postoperatively.
Time frame: 4 hours postoperatively
Heart rate will be recorded immediately before induction of anesthesia, 15 min after performing the block incision and at 20-minute intervals intraoperatively, and then hourly till 4 hours postoperatively.
Time frame: 24 hours postoperatively
Incidence of adverse effects such as nausea, vomiting, hypotension, and bradycardia, pneumothorax, local anesthetic toxicity for up to 24 hours post-surgery will be documented.
Contact information is provided by the study sponsor or research team.
National Cancer Institute, Egypt
Other
Comparison of Costotransverse Foramen Block With Erector Spinae Plane Block in Modified Radical Mastectomy: A Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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