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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study Summary

This trial examined whether adding a nerve block during robot-assisted thoracoscopic surgery for lung resection improves outcomes.

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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Visual Analogue Scale (VAS) Pain Score

Pain medication use

Secondary outcome measures

Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score

M.D. Anderson Symptom Inventory (MDASI) Score

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical College of WisconsinLead Sponsor

609 Previous Clinical Trials

1,162,543 Total Patients Enrolled

AtriCure, Inc.Industry Sponsor

41 Previous Clinical Trials

17,431 Total Patients Enrolled

Mario Gasparri, MDPrincipal InvestigatorMedical College of Wisconsin

Media Library

Intercostal Nerve Cryoablation Clinical Trial Eligibility Overview. Trial Name: NCT05144828 — Phase 4

Lung Disease Research Study Groups: Intercostal Nerve Cryoablation plus Standard of Care (SOC) Pain Control, Standard of Care (SOC) Pain Control

Lung Disease 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What aims is this clinical trial striving to accomplish?

"The primary end-point of this clinical trial, measured over a 14 day period post-operation, is the Visual Analogue Scale Pain Score. Secondary outcomes are Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Score which assesses whether pain experienced may be due to nerve damage; M.D Anderson Symptom Inventory Score used to gauge symptom severity and interference with everyday life; as well as M.D Anderson Symptom Inventory (MDASI) Score measuring worst symptoms in the last 24 hours on a 0-10 numerical rating scale."

Answered by AI

What is the capacity for enrolment in this clinical trial?

"Affirmative. The clinicaltrials.gov portal provides evidence that this trial is actively recruiting participants, which began on February 15th 2022 and was last updated on July 11th 2022. 40 patients need to be obtained from a single site for the study's completion."

Answered by AI

Does the eligibility for this trial stretch to include older individuals?

"This study has an age range criterion of 18-85 years old."

Answered by AI

Has Intercostal Nerve Cryoablation been sanctioned by the FDA?

"The intercostal nerve cryoablation is a treatment that has already been approved, thus it received the highest score of 3 on our safety scale."

Answered by AI

Does this trial have any unfilled vacancies for prospective participants?

"Affirmative. On clinicaltrials.gov, the evidence indicates that this medical experiment is seeking volunteers. It was first posted on February 15th 2022 and most recently revised on July 11th 2022. The research requires 40 subjects from one site to participate in total."

Answered by AI