NCT06754657

CORA-Q15: Continuous vs. Single-injection Interscalene Block on QoR-15 in Outpatient Rotator Cuff Surgery

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)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Pontificia Universidad Catolica de Chile · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

After obtaining approval from the institutional CEC-CCSS and prospective registration of the study at clinicaltrials.org, the investigators will recruit patients who meet the inclusion criteria and provide written consent. Following surgery and placement of the interscalene block with a catheter, in the recovery unit, participants will be assigned to one of two groups according to a random number table, in a 1:1 ratio using block randomization (block sizes of 4, 6, and 8) through sealed envelopes.

Conditions

• Arthropathy Shoulder
• Pain, Acute
• Anesthesia

Interventions

Type	Name	Description
PROCEDURE	Continuous perineural infusion	infusion rate 4 ml/h, with 5 ml boluses (30-minute lockout). The PCA button disabled
PROCEDURE	Single injection	infusion rate 0 ml/h, with 5 ml boluses (30-minute lockout). The PCA button will be enabled for rescue bolus administration

Timeline

• Start date: 2025-05-26
• Primary completion: 2026-12-31
• Completion: 2027-03-31
• First posted: 2025-01-01
• Last updated: 2025-05-30

Locations

1 site across 1 country: Chile