Cryotherapy Effect, Paravertebral Block, Thoracic Surgery, Video-Assisted
Conditions
Brief summary
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.
Detailed description
VATS lung resection is associated with a high incidence of moderate to severe acute thoracic pain. In the postoperative period, optimal analgesia may facilitate recovery, lead to higher patient satisfaction, and lower postoperative complications. Regional analgesia techniques are usually recommended for VATS, and the paravertebral block is often used. However, the duration of the paravertebral block is short (6 to 24 hours), and prolongation of the effect requires the placement of a paravertebral catheter and local anesthetic infusion into the paravertebral space. At our institution, patients with VATS lung resections are often discharged home 24-48 hours after surgery. Intercostal cryoanalgesia has an onset of about 12 hours, which coincides with the weaning of the single-injection paravertebral block. Analgesia is usually prolonged over several weeks, does not require catheter placement, and is not associated with hemodynamic side effects. These characteristics may allow rapid recovery and safe home discharge after VATS lung resection. 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.
Interventions
CO2 Cryoanalgesia AND paravertebral block with Bupivacaine 0.5%
PROCEDURESingle-injection paravertebral block
Paravertebral block with Bupivacaine 0.5%
Sponsors
Centre hospitalier de l'Université de Montréal (CHUM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Quadruple
Intervention model description
Intervention : intercostal cryoanalgesia + single-injection paravertebral block Control group : single-injection paravertebral block
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute thoracic pain during cough | 24 hours | Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute thoracic pain during cough | 1 hour, 6 hours, 12 hours, 18 hours, 48 hours and 7 days | Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst) |
| Postoperative morphine-equivalents consumption | 7 days | Using a Patient Controlled Analgesia (PCA) pump for the first 24 hours, then daily |
| QoR-15 score : 0 (worst) to 150 (best) | Preoperative and 48 hours postoperative | QoR-15 is a score evaluating the quality of recovery after surgery and anesthesia |
| Hypoesthesia over the ipsilateral thorax | 24 hours | Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament |
| Acute thoracic pain at rest | 1 hour, 6 hours, 12 hours, 18 hours, 24 hours, 48 hours and 7 days | Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst) |
| Time to hospital discharge | 30 days | Total time between the end of surgery and prescription for hospital discharge |
| Evaluation of sedation related to opioid consumption | 7 days | Using the Ramsay score (1 to 6) |
| Incidence of vomiting related to opioid consumption | 7 days | Evaluation for vomiting (yes or no) |
| Incidence of pruritus related to opioid consumption | 7 days | Evaluation for pruritus (yes or no) |
| Incidence of nausea related to opioid consumption | 7 days | Evaluation for nausea (yes or no) |
Countries
Canada
Outcome results
None listed