Clinical trial NCT05884099: Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection
Official title: Intercostal Cryoanalgesia for Prevention of Chronic Postoperative Pain Following Video-assisted Thoracoscopic Lung Cancer Resection
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cryotherapy Effect
Chronic Pain
Lung Cancer
Surgery
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention : intercostal cryoanalgesia + single-injection paravertebral block Control group : single-injection paravertebral block
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of persistent thoracic pain
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of persistent thoracic pain
timeFrame: 1 and 6 months
measure: Severity of persistent thoracic pain
timeFrame: 1,3 and 6 months
measure: Incidence of persistent opioid consumption
timeFrame: 1,3 and 6 months
measure: Incidence of postoperative neuropathic pain
timeFrame: 48 hours, 1 month and 6 months
measure: Incidence of new prescription for neuropathic pain medication
timeFrame: 1, 3 and 6 months
measure: Persistent hypoesthesia over the ipsilateral thorax
timeFrame: 1 and 6 months
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal
state: Quebec
Study officials:
affiliation: Centre Hospitalier de l'Universite de Montreal
name: Alex Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.