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

Pontificia Universidad Catolica de Chile

Status and phase: Enrolling; Phase 4

Conditions: Pain, Acute; Arthropathy Shoulder; Anesthesia

Treatments: Procedure: Continuous perineural infusion; Procedure: Single injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06754657

240829017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

Infusion

Active Comparator group

Description:

Patients infusion rate will be set to 4 ml/h, with 5 ml boluses (30-minute lockout). The PCA button will be disabled for rescue bolus administration.

Treatment:

Procedure: Single injection

Bolus

Experimental group

Description:

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

Treatment:

Procedure: Continuous perineural infusion