RecruitingPhase 4NCT06754657

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)


Sponsor

Pontificia Universidad Catolica de Chile

Enrollment

150 participants

Start Date

May 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria3

  • 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 Criteria4

  • 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.

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Interventions

PROCEDUREContinuous perineural infusion

infusion rate 4 ml/h, with 5 ml boluses (30-minute lockout). The PCA button disabled

PROCEDURESingle injection

infusion rate 0 ml/h, with 5 ml boluses (30-minute lockout). The PCA button will be enabled for rescue bolus administration


Locations(1)

Red de Salud UC Christus

Santiago, Chile

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NCT06754657


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