Clinical trial NCT06754657: CORA-Q15: Continuous vs. Single-injection Interscalene Block on QoR-15 in Outpatient Rotator Cuff Surgery
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Arthropathy Shoulder
Pain, Acute
Anesthesia
Keywords: ambulatory surgery
rotator cuff repair
regional anesthesia
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, blinded, two-group clinical trial with a two-stage analysis (non-inferiority followed by superiority, if applicable).
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Daily score on the "Quality of Recovery-15" (QoR-15) scale during the first 3 postoperative days.
timeFrame: Preoperative score and daily score during the first 3 postoperative days.
Secondary outcomes:
measure: Opioid consumption during the first 3 postoperative days
timeFrame: Daily consumption during the first 3 postoperative days.
measure: Daily Numeric Rating Score (NRS) during the first 3 postoperative days
timeFrame: Daily NRS during the first 3 postoperative days
measure: Rate of consultations/readmissions
timeFrame: During the first 3 postoperative days
measure: Rate of rescue analgesic (bolus) during the first 3 postoperative days
timeFrame: During the first 3 postoperative days
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Red de Salud UC Christus
Study officials:
References:
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