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NCT06754657 | NOT YET RECRUITING | Arthropathy Shoulder

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

Pontifical Catholic University of Chile

Brief Summary:

The purpose of our 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 our Acute Pain Unit during the first 3 days.

Condition or disease

Arthropathy Shoulder

Pain, Acute

Anesthesia

Intervention/treatment

Continuous perineural infusion

Single injection

Phase

NA

Detailed Description:

After obtaining approval from the institutional CEC-CCSS and prospective registration of the study at clinicaltrials.org, we 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
Estimated Enrollment : 150 participants
Masking : TRIPLE
Masking Description : Due to the nature of the intervention, both patients and healthcare personnel involved in the intraoperative and postoperative care of the patients will be blinded to the intervention. The PCA button for administering rescue boluses will be stored inside an opaque bag, containing the pump and button, so it will not be available for initial use by the volunteers. The control group will have the infusion activated and the bolus button clamped, while the intervention group will have the infusion set to zero and the bolus button unclamped.
Primary Purpose : TREATMENT
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)
Actual Study Start Date : 2025-03
Estimated Primary Completion Date : 2026-06
Estimated Study Completion Date : 2027-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
CORA-Q15: Continuous vs. Single-injection Interscalene Block on QoR-15 in Outpatient Rotator Cuff Surgery

Location Details

NCT06754657

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