Tokyo, April 6 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061112) titled 'Comparison of postoperative analgesia between interscalene and supraclavicular brachial plexus block for proximal humerus fracture surgery' on April 6.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Single blind -participants are blinded Control - Active

Primary Sponsor: Institute - Department of Anesthesiology, Nagasaki Rosai Hospital

Condition: Condition - proximal humerus fracture Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - A comparative study of the postoperative analgesic effects of the interscalene nerve block (ISB) and the supraclavicular brachial plexus block (SCB) in patients with proximal humeral fractures Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - The procedure is performed under total intravenous anesthesia with remimazolam and remifentanil, with the dosage adjusted to maintain a BIS score within the range of 40-60. Fentanyl 250 ug is administered concurrently as an intraoperative analgesic. The nerve block is performed prior to induction of anesthesia. In the ISB group, 20 mL (50 mg) of 0.25% levobupivacaine is administered for the ultrasound-guided ISB. At the end of the surgery, 15 mg/kg of acetaminophen is administered, with additional doses given at 6, 12, 18, and 24 hours postoperatively. If pain persists despite this, rescue analgesics are administered. Interventions/Control_2 - The procedure is performed under total intravenous anesthesia with remimazolam and remifentanil, with the dosage adjusted to maintain a BIS score within the range of 40-60. Fentanyl 250 ug is administered concurrently as an intraoperative analgesic. The nerve block is performed prior to induction of anesthesia. In the SCB group, 20 mL (50 mg) of 0.25% levobupivacaine is administered for the ultrasound-guided SCB. At the end of the surgery, 15 mg/kg of acetaminophen is administered, with additional doses given at 6, 12, 18, and 24 hours postoperatively. If pain persists despite this, rescue analgesics are administered.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Adult patients with an ASA-PS 1 or 2 undergoing surgery for a proximal humerus fracture Key exclusion criteria - Patients with cardiac dysfunction, liver dysfunction, Kidney dysfunction, respiratory dysfunction, allergy to the medication used, local infection at the puncture site and difficulty communicating Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 03 Month 22 Day Date of IRB - 2026 Year 03 Month 23 Day Anticipated trial start date - 2026 Year 04 Month 06 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069931

Disclaimer: Curated by HT Syndication.