Cryoanalgesia for Post-Surgical Chronic Pain in Lung Cancer

(CRYO-VATS-2 Trial)

Overseen By Evangelos Koliakos, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

Must not be taking: Opioids, Tricyclics, Gabapentinoids, others

Disqualifiers: Thoracic pain, Opioid use, Pregnancy, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Surgery day

80 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Alex Moore, MD

Principal Investigator

Centre Hospitalier de l'Universite de Montreal

Eligibility Criteria

This trial is for patients with lung cancer who are fit (ASA score 1-3) and scheduled for VATS lung resection surgery. It's not suitable for those who can't understand pain scales, have certain drug contraindications, pre-existing thoracic or shoulder pain, specific cold-related conditions, coagulopathy issues, a preference for epidural analgesia due to high risk of thoracotomy or poor lung function, previous thoracic surgery on the same side, regular opioid use or pregnancy.

Inclusion Criteria

I am scheduled for a specific lung surgery for cancer.

My health is good to moderately impaired according to the ASA score.

Exclusion Criteria

I regularly use pain medication for nerve pain.

I had surgery for lung issues, not just a simple removal.

You cannot understand how to measure pain or communicate clearly even after being taught how to do so.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo VATS lung resection with intercostal cryoanalgesia and/or single-injection paravertebral block

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for persistent thoracic pain, hypoesthesia, and opioid consumption

6 months

Multiple visits (in-person and virtual) at 1, 3, and 6 months

Treatment Details

Interventions

• Intercostal Cryoanalgesia
• Single-injection Paravertebral Block

Trial Overview The study tests if intercostal cryoanalgesia combined with a single-injection paravertebral block can prevent chronic pain after VATS lung resection better than just the injection alone. Participants will be divided into two groups: one receiving both treatments and the other only the injection.

Participant Groups

Group I: Intercostal cryoanalgesia AND single-injection paravertebral block Experimental Treatment 1 Intervention

* 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.

Group II: Single-injection paravertebral block Active Control 1 Intervention

-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

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+