Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy

Purpose

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

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Control Arm 		Control Arm: Surgery without intercostal Cryoanalgesia + Standard of Care (thoracic epidural)
  • Procedure: Thoracic Epidural
    The control arm will receive standard of care pain management which includes a Thoracic Patient Controlled Epidural
Experimental
Study Arm 		Study Arm: Surgery with intercostal Cryoanalgesia + Standard of Care (thoracic epidural)
  • 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

Recruiting Locations

University of Maryland Medical Center
Baltimore, Maryland 21201
Contact:
Melissa Culligan, RN, MS
215-570-0854
mculligan@som.umaryland.edu

More Details

Status
Unknown status
Sponsor
University of Maryland, Baltimore

Study Contact

Melissa Culligan, RN, MS
410-328-6366
mculligan@som.umaryland.edu

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.