Clinical trial NCT03538340: Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy
Official title: Randomized, Single-Blinded, Controlled Trial Using Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy: ICE Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Post-thoracotomy Pain
Acute Post-thoracotomy Pain
Post-thoracotomy Pain Syndrome
Keywords: Thoracotomy
Cryoanalgesia
Pain
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: AtriCure, Inc.
First posted: 2018-05-29
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Total narcotic use post-thoracotomy.
timeFrame: 6 months
Secondary outcomes:
measure: Visual Analog Scale (VAS) Assessment of post-thoracotomy pain
timeFrame: 6 months
measure: Quality of Life (SF-36) changes from baseline to 6-months
timeFrame: 6 months
measure: Allodynia Assessment
timeFrame: 6 months
measure: Mankoski Pain Scale Assessment of post-thoracotomy pain
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: U Maryland, Baltimore
name: Joseph S Friedberg, MD
role: PRINCIPAL_INVESTIGATOR
References: