Comparing two types of anesthesia for shoulder surgery recovery
Comparison of Continuous vs. Single-injection Interscalene Block on QoR-15 in Outpatient Rotator Cuff Surgery: A Randomized Study Assessing Non-inferiority and Superiority (CORA-Q15)
PHASE4 · Pontificia Universidad Catolica de Chile · NCT06754657
This study tests whether a single injection or a continuous drip of anesthesia helps adults recover better after shoulder surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Pontificia Universidad Catolica de Chile (other) |
| Locations | 1 site (Santiago) |
| Trial ID | NCT06754657 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of a single-injection interscalene block versus a continuous interscalene block on the quality of recovery in patients undergoing outpatient arthroscopic rotator cuff repair surgery. Participants will be randomly assigned to receive one of the two anesthesia methods and will be monitored for pain levels, recovery quality, and any complications through follow-up calls and assessments. The study will involve adults aged 18 to 75 who are capable of managing a continuous outpatient regional analgesia system and will be conducted at a healthcare center in Santiago, Chile.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 scheduled for elective outpatient arthroscopic rotator cuff repair surgery.
Not a fit: Patients with a history of chronic opioid use, severe comorbidities, or allergies to the study medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve pain management and recovery outcomes for patients undergoing rotator cuff surgery.
How similar studies have performed: Previous studies have shown promising results with similar approaches to regional anesthesia, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults (≥18 years, \< 75 years) scheduled for elective outpatient arthroscopic rotator cuff repair surgery. * Patients capable of managing a continuous outpatient regional analgesia system based on an interscalene block (eligibility criteria: able to understand verbal and written instructions, have home support, and live geographically close to the healthcare center). * Willing and able to provide informed, written consent to participate in the study. Exclusion Criteria: * History of chronic opioid use (\>3 months). * Severe comorbidities (e.g., renal or hepatic failure, ASA classification of 3 or higher). * Allergy to local anesthetics, dexamethasone, or the analgesic drugs used in the study. * Patients with contraindications for peripheral nerve block.
Where this trial is running
Santiago
- Red de Salud UC Christus — Santiago, Chile (RECRUITING)
Study contacts
- Study coordinator: Fernando R Altermatt, MD
- Email: falterma@uc.cl
- Phone: 56955049115
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.
Conditions: Arthropathy Shoulder, Pain, Acute, Anesthesia, ambulatory surgery, rotator cuff repair, regional anesthesia