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Intercostal Cryoanalgesia for Postoperative Pain in Lung Surgery

Phase 4
Waitlist Available
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
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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 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

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.

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor
635 Previous Clinical Trials
1,181,662 Total Patients Enrolled
3 Trials studying Postoperative Pain
301 Patients Enrolled for Postoperative Pain
AtriCure, Inc.Industry Sponsor
42 Previous Clinical Trials
18,731 Total Patients Enrolled
Mario Gasparri, MDPrincipal InvestigatorMedical College of Wisconsin
Maria Gasparri, MDPrincipal InvestigatorMedical College of Wisconsin

Media Library

Intercostal Nerve Cryoablation Clinical Trial Eligibility Overview. Trial Name: NCT05144828 — Phase 4
Postoperative Pain Research Study Groups: Intercostal Nerve Cryoablation plus Standard of Care (SOC) Pain Control, Standard of Care (SOC) Pain Control
Postoperative Pain Clinical Trial 2023: Intercostal Nerve Cryoablation Highlights & Side Effects. Trial Name: NCT05144828 — Phase 4
Intercostal Nerve Cryoablation 2023 Treatment Timeline for Medical Study. Trial Name: NCT05144828 — Phase 4
~10 spots leftby Dec 2025