Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
ID06754657

Comparison of Continuous vs. Single-injection Interscalene Block on Quality of Recovery in Outpatient Arthroscopic Rotator Cuff Surgery

Led by Pontificia Universidad Catolica de Chile · Updated on 2025-05-30

150

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are comparing two methods of pain control called single-injection interscalene block and continuous interscalene block in patients undergoing outpatient arthroscopic rotator cuff repair surgery. This study evaluates which method provides better quality of recovery by measuring pain and other recovery factors after surgery. The study is randomized and triple-blinded to ensure reliable comparison between the two techniques. Participants will be randomly assigned to receive either a single injection of anesthetic or a continuous infusion via a catheter with an elastomeric pump. The continuous infusion group will have a set infusion rate of 4 ml per hour with additional boluses available every 30 minutes, while the single-injection group will receive no continuous infusion but can use the bolus option for pain relief. Both groups will be monitored closely during the first three days after surgery. During the study, participants will be contacted by telephone for surveys assessing their recovery quality, pain levels, opioid use, and any complications. They will also have follow-up care by the Acute Pain Unit for the first three days. The main outcome measured is the daily Quality of Recovery-15 (QoR-15) score over three postoperative days. Additional measures include opioid consumption, pain scores, rates of additional consultations or readmissions, and use of rescue analgesics. Participation lasts through the immediate postoperative period with detailed monitoring to assess recovery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older and younger than 75 years
  • Scheduled for elective outpatient arthroscopic rotator cuff repair surgery
  • Able to manage a continuous outpatient regional analgesia system, including understanding instructions, having home support, and living close to the healthcare center
  • Willing and able to provide written informed consent
Not Eligible

You will not qualify if you...

  • History of chronic opioid use for more than 3 months
  • Severe health conditions such as renal or hepatic failure or ASA classification of 3 or higher
  • Allergy to local anesthetics, dexamethasone, or analgesic drugs used in the study
  • Contraindications for peripheral nerve block

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 3 days

Participants undergo outpatient arthroscopic rotator cuff surgery followed by assignment to either continuous perineural infusion or single injection interscalene block for postoperative pain management.

Daily visits or contacts during the first 3 postoperative days

Trial Site Locations

Total: 1 location

1

Red de Salud UC Christus

Santiago, Chile, 8330024

Actively Recruiting

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Research Team

F

Fernando R Altermatt, MD

V

Victor Contreras, MSN

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Ambulatory continuous interscalene nerve blocks decrease the time to discharge readiness after total shoulder arthroplasty: a randomized, triple-masked, placebo-controlled study.

Brian M Ilfeld, Krista Vandenborne, Pamela W Duncan...

https://pubmed.ncbi.nlm.nih.gov/17065895

Development and longitudinal validation of the overall benefit of analgesia score: a simple multi-dimensional quality assessment instrument.

N Lehmann, G P Joshi, D Dirkmann...

https://pubmed.ncbi.nlm.nih.gov/20693179