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Thoracic Epidural for Post Thoracotomy Pain (ICE Trial)

N/A

Waitlist Available

Led By Joseph S Friedberg, MD

Research Sponsored by University of Maryland, Baltimore

Eligibility Criteria Checklist

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

Must have

Patients undergoing unilateral thoracotomy for non-cardiac surgery

Age 18-85 years of age; male or female

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

ICE Trial Summary

This trial will compare a standard pain relief method with a new one that involves freezing the nerves.

Eligible Conditions

Acute Post-Thoracotomy Pain
Post Thoracotomy Pain Syndrome
Chronic Post-Thoracotomy Pain

ICE Trial Eligibility Criteria

Inclusion Criteria

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

ICE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

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

Treatment Details

Study Objectives

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

Primary outcome measures

Total narcotic use post-thoracotomy.

Secondary outcome measures

Allodynia Assessment

Mankoski Pain Scale Assessment of post-thoracotomy pain

Quality of Life (SF-36) changes from baseline to 6-months

+1 more

ICE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Study ArmExperimental Treatment2 Interventions

Study Arm: Surgery with intercostal Cryoanalgesia + Standard of Care (thoracic epidural)

Group II: Control ArmActive Control1 Intervention

Control Arm: Surgery without intercostal Cryoanalgesia + Standard of Care (thoracic epidural)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Thoracic Epidural

2021

N/A

~80

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Maryland, BaltimoreLead Sponsor

685 Previous Clinical Trials

372,958 Total Patients Enrolled

AtriCure, Inc.Industry Sponsor

41 Previous Clinical Trials

17,333 Total Patients Enrolled

Joseph S Friedberg, MDPrincipal InvestigatorU Maryland, Baltimore

Frequently Asked Questions

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

What is the enrollment capacity of this research trial?

"Affirmative. Data displayed on clinicaltrials.gov verifies that this medical study, which went public on September 1st 2018, is actively seeking participants. About 138 volunteers need to be sourced from a single site."

Answered by AI

Are there any available slots remaining for this clinical research?

"This clinical trial is still open for enrollment, as evidenced by the fact its last update was on April 23rd 2021. It has been available since September 1st 2018."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy

Joseph S. Friedberg, MD 2018. "Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03538340.