CORA-Q15: Continuous vs. Single-injection Interscalene Block on QoR-15 in Outpatient Rotator Cuff Surgery
NCT ID: NCT06754657
Last Updated: 2025-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
150 participants
INTERVENTIONAL
2025-05-26
2027-03-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
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.
Study Groups
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Infusion
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.
Single injection
infusion rate 0 ml/h, with 5 ml boluses (30-minute lockout). The PCA button will be enabled for rescue bolus administration
Bolus
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.
Continuous perineural infusion
infusion rate 4 ml/h, with 5 ml boluses (30-minute lockout). The PCA button disabled
Interventions
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Continuous perineural infusion
infusion rate 4 ml/h, with 5 ml boluses (30-minute lockout). The PCA button disabled
Single injection
infusion rate 0 ml/h, with 5 ml boluses (30-minute lockout). The PCA button will be enabled for rescue bolus administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Pontificia Universidad Catolica de Chile
OTHER
Responsible Party
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Locations
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Red de Salud UC Christus
Santiago, , Chile
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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240829017
Identifier Type: -
Identifier Source: org_study_id
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