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

NCT06754657 | Recruiting Phase 4 DMC

• 1 other identifier: 240829017
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Arthropathy Shoulder; Pain, Acute; Anesthesia

Keywords

ambulatory surgery; rotator cuff repair; regional anesthesia

Outcome Measures

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.

  Preoperative score and daily score during the first 3 postoperative days.

Secondary Outcomes (4)

• Opioid consumption during the first 3 postoperative days

  Daily consumption during the first 3 postoperative days.

• Daily Numeric Rating Score (NRS) during the first 3 postoperative days

  Daily NRS during the first 3 postoperative days

• Rate of consultations/readmissions

  During the first 3 postoperative days

• Rate of rescue analgesic (bolus) during the first 3 postoperative days

  During the first 3 postoperative days

Study Arms (2)

Infusion

ACTIVE COMPARATOR

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

Bolus

EXPERIMENTAL

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

Interventions

Continuous perineural infusion PROCEDURE

infusion rate 4 ml/h, with 5 ml boluses (30-minute lockout). The PCA button disabled

Bolus

Single injection PROCEDURE

infusion rate 0 ml/h, with 5 ml boluses (30-minute lockout). The PCA button will be enabled for rescue bolus administration

Infusion

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Red de Salud UC Christus

Santiago, 8330024, Chile

RECRUITING

Related Publications (14)

• Chou LB, Wagner D, Witten DM, Martinez-Diaz GJ, Brook NS, Toussaint M, Carroll IR. Postoperative pain following foot and ankle surgery: a prospective study. Foot Ankle Int. 2008 Nov;29(11):1063-8. doi: 10.3113/FAI.2008.1063.

  PMID: 19026197 BACKGROUND

• Joshi G, Gandhi K, Shah N, Gadsden J, Corman SL. Peripheral nerve blocks in the management of postoperative pain: challenges and opportunities. J Clin Anesth. 2016 Dec;35:524-529. doi: 10.1016/j.jclinane.2016.08.041. Epub 2016 Oct 20.

  PMID: 27871587 BACKGROUND

• Neal JM, Gerancher JC, Hebl JR, Ilfeld BM, McCartney CJ, Franco CD, Hogan QH. Upper extremity regional anesthesia: essentials of our current understanding, 2008. Reg Anesth Pain Med. 2009 Mar-Apr;34(2):134-70. doi: 10.1097/AAP.0b013e31819624eb.

  PMID: 19282714 BACKGROUND

• Xu J, Chen XM, Ma CK, Wang XR. Peripheral nerve blocks for postoperative pain after major knee surgery. Cochrane Database Syst Rev. 2014;(12):CD010937. doi: 10.1002/14651858.CD010937.pub2. Epub 2014 Dec 11.

  PMID: 25501884 BACKGROUND

• Ilfeld BM, Vandenborne K, Duncan PW, Sessler DI, Enneking FK, Shuster JJ, Theriaque DW, Chmielewski TL, Spadoni EH, Wright TW. Ambulatory continuous interscalene nerve blocks decrease the time to discharge readiness after total shoulder arthroplasty: a randomized, triple-masked, placebo-controlled study. Anesthesiology. 2006 Nov;105(5):999-1007. doi: 10.1097/00000542-200611000-00022.

  PMID: 17065895 BACKGROUND

• Pehora C, Pearson AM, Kaushal A, Crawford MW, Johnston B. Dexamethasone as an adjuvant to peripheral nerve block. Cochrane Database Syst Rev. 2017 Nov 9;11(11):CD011770. doi: 10.1002/14651858.CD011770.pub2.

  PMID: 29121400 BACKGROUND

• Lehmann N, Joshi GP, Dirkmann D, Weiss M, Gulur P, Peters J, Eikermann M. Development and longitudinal validation of the overall benefit of analgesia score: a simple multi-dimensional quality assessment instrument. Br J Anaesth. 2010 Oct;105(4):511-8. doi: 10.1093/bja/aeq186. Epub 2010 Aug 6.

  PMID: 20693179 BACKGROUND

• Mascha EJ, Turan A. Joint hypothesis testing and gatekeeping procedures for studies with multiple endpoints. Anesth Analg. 2012 Jun;114(6):1304-17. doi: 10.1213/ANE.0b013e3182504435. Epub 2012 May 3.

  PMID: 22556210 BACKGROUND

• Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology. 2013 Jun;118(6):1332-40. doi: 10.1097/ALN.0b013e318289b84b.

  PMID: 23411725 BACKGROUND

• Chazapis M, Walker EM, Rooms MA, Kamming D, Moonesinghe SR. Measuring quality of recovery-15 after day case surgery. Br J Anaesth. 2016 Feb;116(2):241-8. doi: 10.1093/bja/aev413.

  PMID: 26787793 BACKGROUND

• Myles PS, Myles DB. An Updated Minimal Clinically Important Difference for the QoR-15 Scale. Anesthesiology. 2021 Nov 1;135(5):934-935. doi: 10.1097/ALN.0000000000003977. No abstract available.

  PMID: 34543410 BACKGROUND

• Admiraal M, Smulders PSH, Rutten MVH, de Groot EK, Heine Y, Baumann HM, van der Vegt VHC, Halm JA, Hermanns H, Schepers T, Hollmann MW, Hermanides J, Ten Hoope W. The effectiveness of ambulatory continuous popliteal sciatic nerve blockade on patient-reported overall benefit of analgesia in patients undergoing foot or ankle surgery (CAREFREE trial); a randomized, open label, non-inferiority trial. J Clin Anesth. 2024 Aug;95:111451. doi: 10.1016/j.jclinane.2024.111451. Epub 2024 Apr 3.

  PMID: 38574504 BACKGROUND

• Morales-Ariza V, Loaiza-Aldean Y, de Miguel M, Pena-Navarro M, Martinez-Silva O, Gonzalez-Tallada A, Manrique-Munoz S, de Nadal M. Validation and cross-cultural adaptation of the postoperative quality of recovery 15 (QoR-15) questionnaire for Spanish-speaking patients: A prospective cohort study. Am J Surg. 2023 Apr;225(4):740-747. doi: 10.1016/j.amjsurg.2022.11.009. Epub 2022 Nov 17.

  PMID: 36414472 BACKGROUND

• Aliste J, Layera S, Bravo D, Aguilera G, Erpel H, Garcia A, Lizama M, Finlayson RJ, Tran D. Randomized comparison between perineural dexamethasone and combined perineural dexamethasone-dexmedetomidine for ultrasound-guided infraclavicular block. Reg Anesth Pain Med. 2022 Jun 21:rapm-2022-103760. doi: 10.1136/rapm-2022-103760. Online ahead of print.

  PMID: 35728840 BACKGROUND

MeSH Terms

Conditions

Acute Pain

Interventions

Injections

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Fernando R Altermatt, MD

CONTACT

56955049115; falterma@uc.cl

Victor Contreras, MSN

CONTACT

56223543414; vecontre@uc.cl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, blinded, two-group clinical trial with a two-stage analysis (non-inferiority followed by superiority, if applicable).

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 1, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: May 30, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)