Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy

NCT ID: NCT03538340

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2023-01-31

Brief 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.

Detailed Description

The ICE Study is a single institution pilot study designed to compare standard therapy (i.e., thoracic epidural) versus a novel approach (i.e., Cryoanalgesia combined with thoracic epidural) to address the need for better management of acute and long-term pain in the general thoracic surgery patient population. The study's primary objective will be to demonstrate if the new intraoperative pain management approach [i.e., intercostal Cryoanalgesia in conjunction with thoracic epidural] provides superior short-term and long-term analgesia efficacy in patients undergoing unilateral thoracotomy as compared to the current institutional standard of care (i.e., thoracic epidural). Patients will be randomized in a 1:1 design.

Conditions

Chronic Post-thoracotomy Pain; Acute Post-thoracotomy Pain; Post-thoracotomy Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Control Arm

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

Group Type: ACTIVE_COMPARATOR

Thoracic Epidural

Intervention Type: PROCEDURE

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

Study Arm

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

Group Type: EXPERIMENTAL

Thoracic Epidural

Intervention Type: PROCEDURE

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

Intercostal Cryoanalgesia

Intervention Type: PROCEDURE

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

Interventions

Thoracic Epidural

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

Intervention Type: PROCEDURE

Intercostal Cryoanalgesia

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients undergoing unilateral thoracotomy for non-cardiac surgery
• Age 18-85 years of age; male or female
• Acceptable surgical candidate including use of general anesthesia
• Willing and able to provide written informed consent
• Willing and able to return for scheduled follow-up visits

Exclusion Criteria

• Prior major surgery within the last 6-months
• Documented psychiatric disease
• Documented chronic pain syndrome
• Current use of prescription opioids
• Documented history of substance abuse
• Functional disability or impairment (ECOG score = 0 or 1)
• Current pregnancy
• Patients currently enrolled in another research study that could directly affect results of either study
• Physical or mental condition that would interfere with patient's self-assessment of pain
• A medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study or interferes with the pain assessments

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AtriCure, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

Joseph S. Friedberg, MD

Professor; Surgeon-in-Chief, UMMS Division of Thoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph S Friedberg, MD

Role: PRINCIPAL_INVESTIGATOR

U Maryland, Baltimore

Locations

University of Maryland Medical Center

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Melissa Culligan, RN, MS

Role: CONTACT

mculligan@som.umaryland.edu

410-328-6366

Facility Contacts

Melissa Culligan, RN, MS

Role: primary

mculligan@som.umaryland.edu

215-570-0854

Other Identifiers

HP-00079115

Identifier Type: -

Identifier Source: org_study_id