Rotator Cuff Injuries Clinical Trial
Official title:
Erector Spinae Plane Block vs. Superior Trunk Block for Postoperative Pain Control After Arthroscopic Shoulder Surgery: a Randomized Controlled Trial
NCT number | NCT05822414 |
Other study ID # | 202301211RINB |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 4, 2023 |
Est. completion date | April 2024 |
To compare the efficacy of pain control, shoulder function recovery, and degree of diaphragm palsy between erector spinae plane block at T2 level and superior trunk block after arthroscopic shoulder surgery
Status | Recruiting |
Enrollment | 100 |
Est. completion date | April 2024 |
Est. primary completion date | April 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility | Inclusion Criteria: - patients receiving arthroscopic shoulder surgery - patients with BMI between 18.5 kg/m^2 and 30 kg/m^2 Exclusion Criteria: - patients with age <18 and >85 - pregnancy - patients with severe organ failure: respiratory failure (FEV1 (Forced expiratory volume) /FVC (orced vital capacity)<70% and FEV1< 50%), heart failure (NYHA class III, IV), renal failure (eGFR<60ml/min/1.73m^2) - patients diagnosed with chronic obstructive lung disease - patients with arrhythmia - patients with ongoing infection - patients with chronic opioid use or substance abuse history - patients with coagulopathy |
Country | Name | City | State |
---|---|---|---|
Taiwan | National Taiwan University Hospital | Taipei | |
Taiwan | National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Ciftci B, Ekinci M, Golboyu BE, Kapukaya F, Atalay YO, Kuyucu E, Demiraran Y. High Thoracic Erector Spinae Plane Block for Arthroscopic Shoulder Surgery: A Randomized Prospective Double-Blind Study. Pain Med. 2021 Apr 20;22(4):776-783. doi: 10.1093/pm/pnaa359. — View Citation
Forero M, Rajarathinam M, Adhikary SD, Chin KJ. Erector spinae plane block for the management of chronic shoulder pain: a case report. Can J Anaesth. 2018 Mar;65(3):288-293. doi: 10.1007/s12630-017-1010-1. Epub 2017 Nov 13. — View Citation
Hussain N, Goldar G, Ragina N, Banfield L, Laffey JG, Abdallah FW. Suprascapular and Interscalene Nerve Block for Shoulder Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2017 Dec;127(6):998-1013. doi: 10.1097/ALN.0000000000001894. — View Citation
Kang R, Jeong JS, Chin KJ, Yoo JC, Lee JH, Choi SJ, Gwak MS, Hahm TS, Ko JS. Superior Trunk Block Provides Noninferior Analgesia Compared with Interscalene Brachial Plexus Block in Arthroscopic Shoulder Surgery. Anesthesiology. 2019 Dec;131(6):1316-1326. — View Citation
Padua R, de Girolamo L, Grassi A, Cucchi D. Choosing patient-reported outcome measures for shoulder pathology. EFORT Open Rev. 2021 Sep 14;6(9):779-787. doi: 10.1302/2058-5241.6.200109. eCollection 2021 Sep. — View Citation
Shanthanna H, Czuczman M, Moisiuk P, O'Hare T, Khan M, Forero M, Davis K, Moro J, Vanniyasingam T, Foster G, Thabane L, Alolabi B. Erector spinae plane block vs. peri-articular injection for pain control after arthroscopic shoulder surgery: a randomised controlled trial. Anaesthesia. 2022 Mar;77(3):301-310. doi: 10.1111/anae.15625. Epub 2021 Dec 3. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of postoperative pain severity | Postoperative pain severity evaluated by 100mm-visual analogue scale (0-100; 0 means no pain at all and 100 means the worst pain intensity) | one hour and 24-hour after surgery | |
Primary | Assessment of diaphragm movement after block performance | Diaphragm movement evaluated by ultrasonography | before surgery and one hour after surgery | |
Secondary | Assessment of postoperative quality of recovery | Postoperative quality of recovery evaluated by quality of recovery 15 (QoR-15) | before surgery and 24 hours after surgery |
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