Comparing pain management techniques after rotator cuff repair
A Study on the Pain Control Effects of Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block and Axillary Nerve Block in Ar-throscopic Rotator Cuff Repair: a Randomized Controlled Trial
This study is testing whether a new pain management technique using specific nerve blocks can help people feel better after rotator cuff surgery compared to a placebo treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Chuncheon Sacred Heart Hospital Academic / other |
| Locations | 2 sites (Chuncheon, Gangwon-do and 1 other locations) |
| Trial ID | NCT06878391 on ClinicalTrials.gov |
What this trial studies
This study is a prospective, randomized, double-blind trial that evaluates the effectiveness of a specific pain management approach for patients undergoing arthroscopic rotator cuff repair. Participants will receive either a combination of interscalene brachial plexus block with suprascapular and axillary nerve blocks or a placebo version of the nerve blocks. Pain scores and patient satisfaction will be assessed at multiple time points postoperatively, alongside blood samples to analyze various biomarkers related to pain and inflammation. The goal is to determine which approach provides better pain relief and overall satisfaction for patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 20 and older with a confirmed rotator cuff tear requiring surgical repair.
Not a fit: Patients who have had previous shoulder surgeries or specific neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing rotator cuff repair.
How similar studies have performed: Other studies have shown promising results with similar nerve block techniques in managing postoperative pain, suggesting this approach is well-supported in the literature.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Chuncheon, Gangwon-do and 1 other locations
- Hallym University Chuncheon Sacred Heart Hospital — Chuncheon, Gangwon-do, South Korea (Not_yet_recruiting)
- Hallym University Chuncheon Sacred Heart Hospital — Chuncheon, Gangwon-do, South Korea (Recruiting)
Study contacts
- Principal investigator: Jung-Taek Hwang, MD, PhD — Hallym University Medical Center
- Study coordinator: Jung-Taek Hwang, MD, PhD
- Email: drakehjt@hanmail.net
- Phone: +82332405197
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.