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Cryoanalgesia for Post-Surgical Chronic Pain in Lung Cancer (CRYO-VATS-2 Trial)

N/A

Waitlist Available

Led By Alex Moore, MD

Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Regular use of opioids or medication with effects against neuropathic pain (tricyclics, gabapentinoids, duloxetine, venlafaxine)

Surgical criteria (conversion to thoracotomy, non anatomical wedge resection)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 48 hours, 1 month and 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a technique to give long-term pain relief after lung surgery to prevent chronic pain.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include localized discomfort from cryotherapy such as numbness or skin changes at the site of application. The paravertebral block could cause soreness where injected and less commonly complications like infection or nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for a specific lung surgery for cancer.

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I regularly use pain medication for nerve pain.

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

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I do not have conditions like cold allergies or cryoglobulinemia.

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I cannot take certain pain relievers due to kidney issues or stomach ulcers.

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I cannot have a paravertebral block due to specific health issues.

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I have had surgery in my chest area before.

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I have pain in my chest or shoulder on the side where I had surgery.

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I do not want to participate in the clinical trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 48 hours, 1 month and 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~48 hours, 1 month and 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 hours, 1 month and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Incidence of new prescription for neuropathic pain medication

Incidence of persistent opioid consumption

Incidence of persistent thoracic pain

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intercostal cryoanalgesia AND single-injection paravertebral blockExperimental Treatment1 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 blockActive Control1 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cryoanalgesia AND single-injection paravertebral block

2023

N/A

~80

0 / 10Eligibility criteria met