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

May 26, 2025 updated by: Pontificia Universidad Catolica de Chile

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Fernando R Altermatt, MD
  • Phone Number: 9115 56955049115
  • Email: falterma@uc.cl

Study Contact Backup

  • Name: Victor Contreras, MSN
  • Phone Number: 3414 56223543414
  • Email: vecontre@uc.cl

Study Locations

  • Chile
      • Santiago, Chile, 8330024
        • Recruiting
        • Red de Salud UC Christus
        • Contact:
          • Victor Contreras, MSN
          • Phone Number: 56981895232
          • Email: vecontre@uc.cl

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Infusion
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.
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
Experimental: Bolus
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.
Procedure: Continuous perineural infusion
infusion rate 4 ml/h, with 5 ml boluses (30-minute lockout). The PCA button disabled

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Daily score on the "Quality of Recovery-15" (QoR-15) scale during the first 3 postoperative days.
Time Frame: 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.
Preoperative score and daily score during the first 3 postoperative days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioid consumption during the first 3 postoperative days
Time Frame: Daily consumption during the first 3 postoperative days.
To assess rescue opioid consumption, expressed as morphine equivalents, during the first three postoperative days.
Daily consumption during the first 3 postoperative days.
Rate of consultations/readmissions
Time Frame: During the first 3 postoperative days
To assess the rate of consultations or readmissions due to pain or other complications in both groups.
During the first 3 postoperative days
Rate of rescue analgesic (bolus) during the first 3 postoperative days
Time Frame: 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.
During the first 3 postoperative days
Daily Numeric Rating Score (NRS) during the first 3 postoperative days
Time Frame: 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.
Daily NRS during the first 3 postoperative days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pontificia Universidad Catolica de Chile

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 26, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

January 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 30, 2025

Last Update Submitted That Met QC Criteria

May 26, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 240829017

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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