Tokyo, March 13 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060910) titled 'A study comparing anesthesia methods to reduce pain after arthroscopic rotator cuff repair: single-shot vs 7-day continuous interscalene block' on March 12.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

Primary Sponsor: Institute - Yamagata University

Condition: Condition - Rotator cuff tear Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to compare the analgesic effects of a preoperative single-shot interscalene brachial plexus block versus a preoperative continuous interscalene block with perineural catheter analgesia (maintained until POD7) in patients undergoing arthroscopic rotator cuff repair, focusing on the postoperative pain trajectory (NRS) and rescue analgesic consumption. We additionally aim to evaluate the time course of the analgesic benefit to determine how long the between-group difference in pain persists postoperatively. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Continuous group (catheter)

Preoperative ultrasound-guided interscalene brachial plexus block with perineural catheter placement. Initial bolus via catheter: ropivacaine 0.375% 10 mL plus dexamethasone sodium phosphate 3.3 mg. Postoperative continuous infusion: ropivacaine 0.2% at 4 mL/h until catheter removal. A 3 mL flush bolus via catheter is allowed for breakthrough pain. Planned catheter removal is POD7; early removal is allowed for adverse events or patient request. Interventions/Control_2 - Single-shot group (control)

Preoperative ultrasound-guided single-shot interscalene brachial plexus block at the same timing as the continuous group. Single bolus: ropivacaine 0.375% 10 mL plus dexamethasone sodium phosphate 3.3 mg.

Eligibility: Age-lower limit - 20 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1.Patients scheduled to undergo arthroscopic rotator cuff repair for rotator cuff tear

2.Eligible to receive a preoperative interscalene brachial plexus block (single-shot or continuous catheter technique)

3.Able to provide written informed consent

4.Age 20 years or older Key exclusion criteria - 1.Allergy, hypersensitivity, or contraindication to ropivacaine or dexamethasone (or local anesthetics)

2.Not suitable for interscalene block (e.g., infection at puncture site, significant coagulation abnormality)

3.Unable to provide reliable pain assessment (NRS) or informed consent due to severe cognitive impairment or psychiatric disorder

4.Revision surgery or concomitant major procedures

5.Severe pulmonary disease where the risk of phrenic nerve palsy is unacceptable

6.Any other condition judged by the investigator to make the patient unsuitable for study participation Target Size - 90

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2019 Year 11 Month 25 Day Date of IRB - 2019 Year 11 Month 25 Day Anticipated trial start date - 2019 Year 12 Month 01 Day Last follow-up date - 2022 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069424

Disclaimer: Curated by HT Syndication.