Intercostal Cryoanalgesia for Chronic Pain After VATS Lung Resection

Lung Cancer Clinical Trial

— CRYO-VATS-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05884099
• Other study ID #: 2024-11564
• Status: Recruiting
• Phase: N/A
• Start date: November 9, 2023
• Est. completion date: November 9, 2025

Study information

• Verified date: January 2024
• Source: Centre hospitalier de l'Université de Montréal (CHUM)
• Contact: Alex Moore, MD
• Phone: 514-890-8000
• Email: alex.moore[@]umontreal.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Pain
• Cryotherapy Effect
• Lung Cancer
• Lung Neoplasms
• Surgery

Intervention

Procedure:
• Cryoanalgesia AND single-injection paravertebral block
CO2 Cryoanalgesia AND paravertebral block with Bupivacaine 0.5%
• Single-injection paravertebral block
Paravertebral block with Bupivacaine 0.5%

Locations

Country	Name	City	State
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Centre hospitalier de l'Université de Montréal (CHUM)

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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

Outcome

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