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

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

NCT ID
NCT03538340
Status
Recruiting
Sponsor
University of Maryland, College Park

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.