Thoracic Surgery Clinical Trial
— CRYO-VATSOfficial title:
Intercostal Cryoanalgesia for Management of Acute Postoperative Pain Following Video-assisted Thoracoscopic Lung Cancer Resection
Intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the management of acute thoracic pain after VATS lung resection surgery.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | November 8, 2025 |
Est. primary completion date | November 9, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients scheduled for elective anatomical pulmonary resection (anatomical segmentectomy, lobectomy or bilobectomy) by VATS for lung cancer - American Society of Anesthesiologists (ASA) score 1-3 Exclusion Criteria: - Contraindication to the paravertebral block (coagulopathy, discontinuous paravertebral space, impossible thoracoscopic visualization of the paravertebral space) - Contraindication to intercostal cryoanalgesia (cold urticaria, cryoglobulinemia) - Epidural analgesia preferred (high risk of thoracotomy, marginal lung function) - Surgical criteria (conversion to thoracotomy, non anatomical wedge resection) - Known allergy to acetaminophen, celecoxib, sulfa or both hydromorphone and morphine - Preoperative thoracic or shoulder pain on the operated side - History of thoracic surgery on the operated site - Regular use of opioids or medication with effects against neuropathic pain (tricyclics, gabapentinoids, duloxetine, venlafaxine) - Inability to understand pain scales or to communicate clearly despite adequate teaching - Contraindication to non-steroidal anti-inflammatory drugs (renal filtration rate < 60 mL/min, active gastric ulcer) - Pregnancy - Patient refusal to participate |
Country | Name | City | State |
---|---|---|---|
Canada | Centre Hospitalier de l'Universite de Montreal | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Acute thoracic pain during cough | Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst) | 24 hours | |
Secondary | Acute thoracic pain at rest | Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst) | 1 hour, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 7 days | |
Secondary | Acute thoracic pain during cough | Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst) | 1 hour, 6 hours, 12 hours, 18 hours, 48 hours and 7 days | |
Secondary | Postoperative morphine-equivalents consumption | Using a Patient Controlled Analgesia (PCA) pump for the first 24 hours, then daily | 7 days | |
Secondary | QoR-15 score : 0 (worst) to 150 (best) | QoR-15 is a score evaluating the quality of recovery after surgery and anesthesia | Preoperative and 48 hours postoperative | |
Secondary | Hypoesthesia over the ipsilateral thorax | Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament | 24 hours | |
Secondary | Incidence of nausea related to opioid consumption | Evaluation for nausea (yes or no) | 7 days | |
Secondary | Time to hospital discharge | Total time between the end of surgery and prescription for hospital discharge | 30 days | |
Secondary | Evaluation of sedation related to opioid consumption | Using the Ramsay score (1 to 6) | 7 days | |
Secondary | Incidence of vomiting related to opioid consumption | Evaluation for vomiting (yes or no) | 7 days | |
Secondary | Incidence of pruritus related to opioid consumption | Evaluation for pruritus (yes or no) | 7 days |
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