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

Phase 4

Not yet recruiting

• Conditions: Arthropathy Shoulder; Pain, Acute; Anesthesia

• Registration Number: NCT06754657
• Lead Sponsor: Pontificia Universidad Catolica de Chile

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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-23
• Study First Submitted QC: 2024-12-23
• Study First Posted: 2025-01-01
• Last Update Submitted: 2025-01-30
• Last Update Posted: 2025-02-03
• Study Start: 2025-03
• Primary Completion: 2026-06
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Daily score on the "Quality of Recovery-15" (QoR-15) scale during the first 3 postoperative days.	Preoperative score and daily score during the first 3 postoperative days.	The QoR-15 is a validated instrument in the literature that assesses the quality of recovery in patients after surgery. It is a multidimensional measurement tool that allows healthcare professionals to gain an overview of the patient's well-being during the postoperative period. The questionnaire consists of 15 items, covering 5 dimensions: Physical Comfort, Physical Independence, Emotional Support, Psychological Well-being, and Satisfaction with Recovery. The minimum score on the scale is 0 points, and the maximum score is 150 points. This range is obtained by summing the scores of the different categories evaluated in the QoR-15 scale, where a higher score indicates a better quality of postoperative recovery.

Secondary Outcome Measures

Name	Time	Method
Opioid consumption during the first 3 postoperative days	Daily consumption during the first 3 postoperative days.	To assess rescue opioid consumption, expressed as morphine equivalents, during the first three postoperative days.
Daily Numeric Rating Score (NRS) during the first 3 postoperative days	Daily NRS during the first 3 postoperative days	The NRS (Numeric Rating Scale) is commonly used to assess pain intensity. Its minimum score is 0, indicating no pain, and its maximum score is 10, indicating the worst pain imaginable. This scale is simple and allows patients to rate their pain using a number from 0 to 10. The objective is to assess the intensity of acute postoperative pain, expressed as NRS, during the first 3 postoperative days.
Rate of consultations/readmissions	During the first 3 postoperative days	To assess the rate of consultations or readmissions due to pain or other complications in both groups.
Rate of rescue analgesic (bolus) during the first 3 postoperative days	During the first 3 postoperative days	In the case that patients do not experience pain relief with the established management, as indicated by persistent NRS ≥ 4 after the administration of more than two rescue tramadol tablets, they will be instructed to call the contact phone number of the Ambulatory Pain Management Unit to receive guidance on how to implement a rescue bolus using the perineural catheter and the bolus option of the elastomeric pump. This event will be documented and recorded with the time of occurrence in a mobile application developed for this purpose.