Cryoanalgesia for Post-Surgical Chronic Pain in Lung Cancer

(CRYO-VATS-2 Trial)

AM
EK
Overseen ByEvangelos Koliakos, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if intercostal cryoanalgesia, a technique that numbs the chest area, can prevent chronic pain after lung surgery. It will compare two approaches: a single-injection paravertebral block (a pain relief injection near the spine) and its combination with intercostal cryoanalgesia. Individuals scheduled for lung cancer surgery using VATS (video-assisted thoracoscopic surgery) may qualify if they do not have conditions that interfere with the pain relief methods being tested. As an unphased trial, this study allows patients to contribute to innovative pain management research following lung surgery.

Do I need to stop taking my current medications for the trial?

The trial requires that you do not regularly use opioids or medications for nerve pain, like tricyclics, gabapentinoids, duloxetine, or venlafaxine. If you are taking these, you may need to stop before participating.

What prior data suggests that intercostal cryoanalgesia is safe for post-surgical chronic pain management in lung cancer patients?

Research has shown that intercostal cryoanalgesia, a technique that reduces pain by freezing nerves, is generally safe and well-tolerated. One study found that this treatment did not increase hospital costs and even helped patients leave the hospital sooner after lung surgery. Another study discovered that it significantly reduced the need for painkillers like opioids and improved pain management in lung transplant patients.

A case report noted that cryoanalgesia provided long-term relief for chest pain with few side effects. Patients experienced better recovery and pain control. Overall, evidence suggests that intercostal cryoanalgesia can be a safe option for managing pain after surgery, with minimal side effects reported.12345

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a novel approach to managing post-surgical chronic pain in lung cancer patients. Unlike standard options, which often rely on systemic pain relief like opioids, this technique uses intercostal cryoanalgesia and a paravertebral block to target pain locally. The cryoanalgesia method involves applying extremely cold temperatures directly to nerves near the surgical area, potentially offering longer-lasting pain relief with fewer side effects. This localized approach could reduce the need for systemic medications, minimizing their associated risks and side effects.

What evidence suggests that intercostal cryoanalgesia and single-injection paravertebral block could be effective for post-surgical chronic pain in lung cancer?

Research has shown that intercostal cryoanalgesia, a treatment under study in this trial, can effectively reduce pain after lung surgery. One study found it helps manage pain in patients who underwent VATS, a type of lung surgery. Another study demonstrated that using it during a lobectomy, the removal of part of the lung, provides better pain relief than standard care. Additionally, cryoanalgesia has reduced the need for opioids, strong painkillers, and lowered pain levels in lung transplant patients. This suggests that intercostal cryoanalgesia could be a promising option for managing long-term pain after surgery in lung cancer patients.13567

Who Is on the Research Team?

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Alex Moore, MD

Principal Investigator

Centre Hospitalier de l'Universite de Montreal

Are You a Good Fit for This Trial?

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.
See 9 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Intercostal cryoanalgesia AND single-injection paravertebral blockExperimental Treatment1 Intervention
Group II: Single-injection paravertebral blockActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials
389
Recruited
143,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/40490216/
Intercostal cryoanalgesia for acute pain after video ...This study aimed to assess the analgesic benefit of intercostal cryoanalgesia in VATS lung cancer surgery. The primary outcome was thoracic ...
Intercostal Nerve Cryoablation During Lobectomy for ...Our results suggest that cryoablation during lobectomy for the treatment of postoperative pain may have some advantages over SOC alone.
Cryoanalgesia for Post-Surgical Chronic Pain in Lung ...Intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. The aim of this study is to demonstrate the ...
Cryoanalgesia in Lung Transplantation – A Systematic ...This meta-analysis indicates that cryoanalgesia effectively reduces opioid requirements and pain levels in lung transplant patients. Graphical ...
Case Report: Cryoanalgesia for intractable thoracic pain ...Conclusion: Cryoanalgesia provides long-term relief for chest pain caused by tumors, with minimal side effects. It improves recovery and should be considered an ...
Intercostal cryoanalgesia for acute pain after video ...This study aimed to assess the analgesic benefit of intercostal cryoanalgesia in VATS lung cancer surgery. The primary outcome was thoracic ...
Intercostal cryoanalgesia for acute pain after video ...This study aimed to assess the analgesic benefit of intercostal cryoanalgesia in VATS lung cancer surgery. The primary outcome was thoracic pain during ...
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