What side effects are associated with this type of intervention?

Cryo Nerve Block, a treatment involving the temporary interruption of pain signal transmission through extreme cold application, is being studied for its efficacy in managing pain during lung resection surgeries. Common side effects of treatments for lung disease, particularly those involving invasive procedures or pharmacotherapy, can include respiratory complications such as hypoxemia, prolonged neuromuscular weakness, and potential pulmonary toxicity. Inhaled nitric oxide, another treatment for acute respiratory distress syndrome (ARDS), has shown short-term benefits but lacks evidence for long-term mortality improvement. Adverse effects of such treatments may include mild irritant reactions and increased lung weights, as observed in some inhalation toxicity studies.

What prior FDA approvals exist?

FDA-approved treatments for lung diseases include a variety of pharmacological and procedural interventions. Pharmacological treatments often involve bronchodilators, corticosteroids, and mucolytic agents to manage symptoms and improve lung function. Procedural interventions include bronchial thermoplasty for severe asthma and various surgical options for conditions like non-small cell lung cancer. While the context does not provide specific FDA approvals for treatments similar to Cryo Nerve Block, it is important to note that such innovative approaches are being explored in clinical trials to enhance pain management and improve patient outcomes in lung disease treatments.

What other types of research exist?

Promising alternatives to Cryo Nerve Block for lung disease patients include: 1) Diaphragm pacing, which has shown efficacy in improving respiratory function in patients with diaphragm dysfunction. 2) Phrenic nerve stimulation, which can mitigate ventilator-induced diaphragm atrophy and improve respiratory outcomes. 3) Topical treatments such as menthol, which have shown rapid symptomatic improvement in neuropathic pain and could be beneficial for managing pain associated with lung disease.

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Intercostal Cryoanalgesia for Postoperative Pain in Lung Surgery

Phase 4

Recruiting

Led By Mario Gasparri, MD

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

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

Must have

18-85 years of age

Be older than 18 years old

Must not have

Patients currently using opioids

Patients undergoing or requiring conversion to thoracotomy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operative month 1, month 3, month 6

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a freezing technique to reduce pain in patients having minimally invasive lung surgery. The tool used freezes nerves to stop them from sending pain signals. This could help patients recover faster and use fewer painkillers. The technique of freezing nerves to manage pain has been used in various surgical procedures, showing effectiveness in reducing postoperative pain.

Who is the study for?

This trial is for adults aged 18-85 who are suitable for surgery and can attend follow-up visits. It's not for those with chronic pain treatment in the last year, a history of heavy alcohol use, current opioid users, or illicit drug users.

What is being tested?

The study tests if adding Cryo Nerve Block to robotic lung surgery helps manage postoperative pain better than standard patient-controlled analgesia alone.

What are the potential side effects?

Potential side effects may include discomfort at the nerve block site, changes in sensation, localized skin reactions, and typical risks associated with anesthesia.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 85 years old.

Exclusion Criteria

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

Select...

I am currently taking opioids for pain.

Select...

I am undergoing or need an open chest surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-operative month 1, month 3, month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-operative month 1, month 3, month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative month 1, month 3, month 6 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Visual Analogue Scale (VAS) Pain Score

Pain medication use

Secondary study objectives

Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score

M.D. Anderson Symptom Inventory (MDASI) Score

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Intercostal Nerve Cryoablation plus Standard of Care (SOC) Pain ControlExperimental Treatment2 Interventions

Intercostal nerve cryoablation using the CryoICE® CRYOS-L cryoablation probe and an intercostal nerve block of nerves 4-9 performed using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin

Group II: Standard of Care (SOC) Pain ControlActive Control1 Intervention

Intercostal nerve block of nerves 4-9 using 0.5% Marcaine with Epinephrine plus prescribed post-operative pain medication, including tramadol, tylenol, and robaxin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intercostal Nerve Cryoablation

2019

Completed Phase 4

~20

Patient-controlled analgesia (PCA)

2019

Completed Phase 4

~20

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lung disease include bronchodilators, which relax the muscles around the airways; anti-inflammatory medications like corticosteroids, which reduce inflammation; and supplemental oxygen, which helps maintain adequate oxygen levels in the blood. Treatments similar to Cryo Nerve Block, such as cryotherapy, involve the application of extreme cold to temporarily interrupt pain signal transmission, providing pain relief and reducing inflammation. Understanding these mechanisms is crucial for lung disease patients as it helps tailor treatments to manage symptoms effectively, improve quality of life, and potentially reduce the need for more invasive procedures.

CRYAB reduces cigarette smoke-induced inflammation, apoptosis, and oxidative stress by retarding PI3K/Akt and NF-κB signaling pathways in human bronchial epithelial cells.Identification of potential genes in endobronchial tuberculosis after bronchoscopic cryotherapy by transcriptome sequencing.The role and source of tumor necrosis factor-α in hemorrhage-induced priming for septic lung injury.