Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-27 @ 3:20 PM
Study NCT ID:
NCT06754657
Status:
RECRUITING
Last Update Posted:
2025-05-30
First Post:
2024-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CORA-Q15: Continuous vs. Single-injection Interscalene Block on QoR-15 in Outpatient Rotator Cuff Surgery
Sponsor:
Pontificia Universidad Catolica de Chile
Organization:
Study Overview
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)
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CORA-Q15
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: