Lung Cancer Clinical Trial
— CRYO-VATS-2Official title:
Intercostal Cryoanalgesia for Prevention of Chronic 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 prevention of chronic thoracic pain after VATS lung resection surgery.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | November 9, 2025 |
Est. primary completion date | May 9, 2025 |
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) - Preoperative thoracic or shoulder pain on the operated side - Known allergy to acetaminophen, celecoxib, sulfa, or both hydromorphone and morphine - 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 | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) |
Canada,
Ilfeld BM, Finneran JJ, Swisher MW, Said ET, Gabriel RA, Sztain JF, Khatibi B, Armani A, Trescot A, Donohue MC, Schaar A, Wallace AM. Preoperative Ultrasound-guided Percutaneous Cryoneurolysis for the Treatment of Pain after Mastectomy: A Randomized, Participant- and Observer-masked, Sham-controlled Study. Anesthesiology. 2022 Nov 1;137(5):529-542. doi: 10.1097/ALN.0000000000004334. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of persistent thoracic pain | Persistent postoperative thoracic pain (yes or no) | 3 months | |
Secondary | Incidence of persistent thoracic pain | Persistent postoperative thoracic pain (yes or no) | 1 and 6 months | |
Secondary | Severity of persistent thoracic pain | Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst), at rest and during cough | 1,3 and 6 months | |
Secondary | Incidence of persistent opioid consumption | Persistent postoperative opioid consumption (yes/no) | 1,3 and 6 months | |
Secondary | Incidence of postoperative neuropathic pain | DN4 score (10 points) ; positive if 4 points or more | 48 hours, 1 month and 6 months | |
Secondary | Incidence of new prescription for neuropathic pain medication | Yes or no | 1, 3 and 6 months | |
Secondary | Persistent hypoesthesia over the ipsilateral thorax | Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament as well as the subjective presence of a sensation of hypoesthesia. | 1 and 6 months |
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