Chronic Pain, Cryotherapy Effect, Lung Cancer, Surgery
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 prevention of chronic thoracic pain after VATS lung resection surgery.
Detailed description
VATS lung resection is associated with a high incidence of persistent thoracic pain. To our knowledge, there is no study on the effect of cryoanalgesia on the incidence and severity of chronic thoracic pain 3 months after VATS lung resection. Intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. In a recent study by Ilfeld & al, intercostal cryoanalgesia (combined with a single-injection paravertebral block) was able to drastically lower the incidence of chronic pain after total mastectomy compared to the use of the paravertebral block alone (3% vs 17%). The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia for the prevention of chronic 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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of persistent thoracic pain | 3 months | Persistent postoperative thoracic pain (yes or no) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity of persistent thoracic pain | 1,3 and 6 months | Numerical Rating Scale (NRS) score : scale 0 (no pain) to 10 (worst), at rest and during cough |
| Incidence of persistent opioid consumption | 1,3 and 6 months | Persistent postoperative opioid consumption (yes/no) |
| Incidence of persistent thoracic pain | 1 and 6 months | Persistent postoperative thoracic pain (yes or no) |
| Incidence of new prescription for neuropathic pain medication | 1, 3 and 6 months | Yes or no |
| Persistent hypoesthesia over the ipsilateral thorax | 1 and 6 months | Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament as well as the subjective presence of a sensation of hypoesthesia. |
| Incidence of postoperative neuropathic pain | 48 hours, 1 month and 6 months | DN4 score (10 points) ; positive if 4 points or more |
Countries
Canada
Outcome results
None listed