Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intercostal Cryoanalgesia for Prevention of Chronic Postoperative Pain Following Video-assisted Thoracoscopic Lung Cancer Resection

Conditions
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Cryotherapy Effect, Chronic Pain, Lung Cancer, Surgery

Intervention / Treatment
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* Procedure: Cryoanalgesia AND single-injection paravertebral block
* Procedure: Single-injection paravertebral block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention : intercostal cryoanalgesia + single-injection paravertebral block Control group : single-injection paravertebral block
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intercostal cryoanalgesia AND single-injection paravertebral block<br>Videothoracoscopic-guided single-injection paravertebral block at T5 with 0.4 mL/kg of Bupivacaine 0.5% with adrenalin 5 mcg/mL (maximum 40 mL) at the beginning of surgery Cryoanalgesia 5 cm lateral to the neuraxial, on the inferior costal border, CO2 at (-)50C to (-)70C for 2 minutes, repeated on 7 costal levels (T3-T9), after the lung resection and before chest closure. | Procedure: Cryoanalgesia AND single-injection paravertebral block<br>* CO2 Cryoanalgesia AND paravertebral block with Bupivacaine 0.5%<br>|
| Active Comparator: Single-injection paravertebral block<br>-Videothoracoscopic-guided single-injection paravertebral block at T5 with 0.4 mL/kg of Bupivacaine 0.5% with adrenalin 5 mcg/mL (maximum 40 mL) at the beginning of surgery | Procedure: Single-injection paravertebral block<br>* Paravertebral block with Bupivacaine 0.5%<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of persistent thoracic pain | Persistent postoperative thoracic pain (yes or no) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of persistent thoracic pain | Persistent postoperative thoracic pain (yes or no) | 1 and 6 months | 
| 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 | 
| Incidence of persistent opioid consumption | Persistent postoperative opioid consumption (yes/no) | 1,3 and 6 months | 
| Incidence of postoperative neuropathic pain | DN4 score (10 points) ; positive if 4 points or more | 48 hours, 1 month and 6 months | 
| Incidence of new prescription for neuropathic pain medication | Yes or no | 1, 3 and 6 months | 
| Persistent hypoesthesia over the ipsilateral thorax | Evaluation of the dermatomal levels of hypoesthesia using a Von Frey monofilament | 1 and 6 months |