CORA-Q15: Continuous vs. Single-injection Interscalene Block on QoR-15 in Outpatient Rotator Cuff Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPontificia Universidad Catolica de Chile
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous perineural infusion
Procedure/Surgeryinfusion rate 4 ml/h, with 5 ml boluses (30-minute lockout). The PCA button disabled
Single injection
Procedure/Surgeryinfusion rate 0 ml/h, with 5 ml boluses (30-minute lockout). The PCA button will be enabled for rescue bolus administration
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: InfusionActive comparator 1 intervention
Group B: BolusExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Daily score on the "Quality of Recovery-15" (QoR-15) scale 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.
Time frame
Preoperative score and daily score during the first 3 postoperative days.Secondary outcomes
1
Opioid consumption during the first 3 postoperative days
To assess rescue opioid consumption, expressed as morphine equivalents, during the first three postoperative days.
Time frame
Daily consumption during the first 3 postoperative days.2
Daily Numeric Rating Score (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.
Time frame
Daily NRS during the first 3 postoperative days3
Rate of consultations/readmissions
To assess the rate of consultations or readmissions due to pain or other complications in both groups.
Time frame
During the first 3 postoperative days4
Rate of rescue analgesic (bolus) 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.
Time frame
During the first 3 postoperative daysSponsors and contacts
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Source ClinicalTrials.gov