دورية أكاديمية
أعرض في EDS

Intercostal nerve cryoablation versus thoracic epidural analgesia for minimal invasive Nuss repair of pectus excavatum: a protocol for a randomised clinical trial (ICE trial).

التفاصيل البيبلوغرافية
العنوان: Intercostal nerve cryoablation versus thoracic epidural analgesia for minimal invasive Nuss repair of pectus excavatum: a protocol for a randomised clinical trial (ICE trial).
المؤلفون: Janssen N; Department of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands., Daemen JHT; Department of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands., Franssen AJPM; Department of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands., van Polen EJ; Department of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands., van Roozendaal LM; Department of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands., Hulsewé KWE; Department of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands., Vissers Y; Department of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands., de Loos ER; Department of Surgery, Division of General Thoracic Surgery, Zuyderland Medical Centre, Heerlen, The Netherlands e.deloos@zuyderland.nl.
المصدر: BMJ open [BMJ Open] 2024 Mar 25; Vol. 14 (3), pp. e081392. Date of Electronic Publication: 2024 Mar 25.
نوع المنشور: Clinical Trial Protocol; Journal Article
اللغة: English
بيانات الدورية: Publisher: BMJ Publishing Group Ltd Country of Publication: England NLM ID: 101552874 Publication Model: Electronic Cited Medium: Internet ISSN: 2044-6055 (Electronic) Linking ISSN: 20446055 NLM ISO Abbreviation: BMJ Open Subsets: MEDLINE
أسماء مطبوعة: Original Publication: [London] : BMJ Publishing Group Ltd, 2011-
مواضيع طبية MeSH: Analgesia, Epidural*/methods , Cryosurgery*/methods , Funnel Chest*/surgery, Humans ; Child ; Adolescent ; Retrospective Studies ; Intercostal Nerves/surgery ; Prospective Studies ; Quality of Life ; Pain, Postoperative/drug therapy ; Analgesics, Opioid/therapeutic use ; Minimally Invasive Surgical Procedures/methods ; Randomized Controlled Trials as Topic
مستخلص: Introduction: Epidural analgesia is currently considered the gold standard in postoperative pain management for the minimally invasive Nuss procedure for pectus excavatum. Alternative analgesic strategies (eg, patient-controlled analgesia and paravertebral nerve block) fail in accomplishing adequate prolonged pain management. Furthermore, the continuous use of opioids, often prescribed in addition to all pain management strategies, comes with side effects. Intercostal nerve cryoablation seems a promising novel technique. Hence, the primary objective of this study is to determine the impact of intercostal nerve cryoablation on postoperative length of hospital stay compared with standard pain management of young pectus excavatum patients treated with the minimally invasive Nuss procedure.
Methods and Analysis: This study protocol is designed for a single centre, prospective, unblinded, randomised clinical trial. Intercostal nerve cryoablation will be compared with thoracic epidural analgesia in 50 young pectus excavatum patients (ie, 12-24 years of age) treated with the minimally invasive Nuss procedure. Block randomisation, including stratification based on age (12-16 years and 17-24 years) and sex, with an allocation ratio of 1:1 will be performed.Postoperative length of hospital stay will be recorded as the primary outcome. Secondary outcomes include (1) pain intensity, (2) operative time, (3) opioid usage, (4) complications, including neuropathic pain, (5) creatine kinase activity, (6) intensive care unit admissions, (7) readmissions, (8) postoperative mobility, (9) health-related quality of life, (10) days to return to work/school, (11) number of postoperative outpatient visits and (12) hospital costs.
Ethics and Dissemination: This protocol has been approved by the local Medical Ethics Review Committee, METC Zuyderland and Zuyd University of Applied Sciences. Participation in this study will be voluntary and informed consent will be obtained. Regardless of the outcome, the results will be disseminated through a peer-reviewed international medical journal.
Trial Registration Number: NCT05731973.
Competing Interests: Competing interests: None declared.
(© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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فهرسة مساهمة: Keywords: Paediatric thoracic surgery; Pain management; Randomized Controlled Trial; Thoracic surgery
سلسلة جزيئية: ClinicalTrials.gov NCT05731973
المشرفين على المادة: 0 (Analgesics, Opioid)
تواريخ الأحداث: Date Created: 20240326 Date Completed: 20240328 Latest Revision: 20240329
رمز التحديث: 20240329
مُعرف محوري في PubMed: PMC10966815
DOI: 10.1136/bmjopen-2023-081392
PMID: 38531584
قاعدة البيانات: MEDLINE
الوصف
تدمد:2044-6055
DOI:10.1136/bmjopen-2023-081392