MedTrace Logo

Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy

NCT03538340 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2021-04-27

No results posted yet for this study

Summary

The ICE Study study will compare standard therapy (thoracic epidural) versus a novel approach (Cryoanalgesia combined with thoracic epidural) in subjects undergoing unilateral thoracotomy.

Conditions

  • Chronic Post-thoracotomy Pain
  • Acute Post-thoracotomy Pain
  • Post-thoracotomy Pain Syndrome

Interventions

PROCEDURE

Thoracic Epidural

The control arm will receive standard of care pain management which includes a Thoracic Patient Controlled Epidural

PROCEDURE

Intercostal Cryoanalgesia

The study arm will receive standard of care pain management which includes a Thoracic Epidural plus Intraoperative Intercostal Cryoanalgesia

Sponsors & Collaborators

  • AtriCure, Inc.

    collaborator INDUSTRY

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Joseph S Friedberg, MD · U Maryland, Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2022-12-31
Completion
2023-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03538340 on ClinicalTrials.gov