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

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)

Overview

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.

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.

Interventions

• Procedure Continuous perineural infusion
  infusion rate 4 ml/h, with 5 ml boluses (30-minute lockout). The PCA button disabled
• Procedure Single injection
  infusion rate 0 ml/h, with 5 ml boluses (30-minute lockout). The PCA button will be enabled for rescue bolus administration

Primary outcome measures

• Daily score on the "Quality of Recovery-15" (QoR-15) scale during the first 3 postoperative days. [Time frame: Preoperative score and daily score during the first 3 postoperative days.]

Secondary outcome measures (4)

• Opioid consumption during the first 3 postoperative days [Time frame: Daily consumption during the first 3 postoperative days.]
• Daily Numeric Rating Score (NRS) during the first 3 postoperative days [Time frame: Daily NRS during the first 3 postoperative days]
• Rate of consultations/readmissions [Time frame: During the first 3 postoperative days]
• Rate of rescue analgesic (bolus) during the first 3 postoperative days [Time frame: During the first 3 postoperative days]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Chile · 1 center

• Red de Salud UC Christus — Santiago

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06754657 · 240829017

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗