NCT06754657 CORA-Q15: Continuous vs. Single-injection Interscalene Block on QoR-15 in Outpatient Rotator Cuff Surgery
| NCT ID | NCT06754657 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Pontificia Universidad Catolica de Chile |
| Condition | Arthropathy Shoulder |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-05-26 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 150 participants in total. It began in 2025-05-26 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study will be to compare the efficacy of single-injection interscalene block versus continuous interscalene block on the quality of recovery in patients undergoing outpatient arthroscopic rotator cuff repair surgery. The participants will: * Be randomized to receive either a single-injection interscalene block or continuous infusion via an elastomeric pump. * Be monitored via telephone by the research team to complete the QoR-15 survey, assess pain levels, the need for tramadol use, and any complications. * Have follow-up by the Acute Pain Unit during the first 3 days.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06754657 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Arthropathy Shoulder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06754657 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06754657 currently recruiting?
Yes, NCT06754657 is actively recruiting participants. Contact the research team at falterma@uc.cl for enrollment information.
Where is the NCT06754657 trial being conducted?
This trial is being conducted at Santiago, Chile.
Who is sponsoring the NCT06754657 clinical trial?
NCT06754657 is sponsored by Pontificia Universidad Catolica de Chile. The trial plans to enroll 150 participants.