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Recruiting Not applicable

ISB With SSNB & ANB

NCT06878391 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2025-03-24
Last updated
2025-05-29

Condition(s) studied

Rotator Cuff Tear

Investigational drug(s) / intervention(s)

Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve block

Preemptive ultrasound-guided interscalene brachial plexus block and suprascapular nerve block and axillary nerve block: Preemptive ultrasound-guided interscalene brachial plexus block using ropivacaine, and suprascapular nerve block and axillary nerve block using ropivacaine or saline. Low fixed dose patient controlled analgesia (PCA) were done in the two group.

Study summary

This study is a prospective, randomized, double-blind trial comparing patients who underwent arthroscopic rotator cuff repair and received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with suprascapular nerve block and axillary nerve block (each with 10 ml of 0.75% ropivacaine) versus those who received an interscalene brachial plexus block (9 ml of 0.75% ropivacaine, 3 ml for each trunk) combined with placebo suprascapular and axillary nerve blocks (each with 10 ml of 0.9% saline).

The study will compare subjective pain scores (VAS score) and patient satisfaction preoperatively and at 1, 3, 6, 12, 18, 24, 36, and 48 hours postoperatively. Additionally, 5 ml of venous blood will be collected preoperatively and at 1, 6, 12, 24, and 48 hours postoperatively to analyze and compare serum levels of cortisol, IL-6, IL-8, IL-1β, substance P, serotonin, β-endorphin, and norepinephrine.

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * a definite rotator cuff tear that needed repair seen on preoperative magnetic resonancce imaging (MRI) * acceptance of arthroscopic surgery including rotator cuff repair * age same as or more than 20 years * acceptance of preemptive regional block and PCA, and blood testing Exclusion Criteria: * did not undergo arthroscopic rotator cuff repair * stopped PCA before 48 hours postoperatively because of associated side effects * a history of previous ipsilateral shoulder operation or fracture * a concomitant neurologic disorder around the shoulder * a failure of blood sampling including hemolysis, etc.

Primary outcome measure(s)

  • visual analog pain scale (VAS) — preoperative, postoperative 1, 3, 6, 12, 18, 24, 36, 48 hour(s)
    0-10, 0: no pain, 10: very severe pain

Trial sites (2)

FacilityCityRegionStatus
Hallym University Chuncheon Sacred Heart Hospital Chuncheon Gangwon-do Not Yet Recruiting
Hallym University Chuncheon Sacred Heart Hospital Chuncheon Gangwon-do Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06878391 on ClinicalTrials.gov ↗ ← All trials in South Korea