Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized, Single-Blinded, Controlled Trial Using Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy: ICE Study

Conditions
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Chronic Post-thoracotomy Pain, Acute Post-thoracotomy Pain, Post-thoracotomy Pain Syndrome

Intervention / Treatment
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* Procedure: Thoracic Epidural
* Procedure: Intercostal Cryoanalgesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Arm<br>Control Arm: Surgery without intercostal Cryoanalgesia + Standard of Care (thoracic epidural) | Procedure: Thoracic Epidural<br>* The control arm will receive standard of care pain management which includes a Thoracic Patient Controlled Epidural<br>|
| Experimental: Study Arm<br>Study Arm: Surgery with intercostal Cryoanalgesia + Standard of Care (thoracic epidural) | Procedure: Thoracic Epidural<br>* The control arm will receive standard of care pain management which includes a Thoracic Patient Controlled Epidural<br>Procedure: Intercostal Cryoanalgesia<br>* The study arm will receive standard of care pain management which includes a Thoracic Epidural plus Intraoperative Intercostal Cryoanalgesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total narcotic use post-thoracotomy. | The primary outcome measure of this study is to determine if the addition of Cryoanalgesia to standard of care post thoracotomy pain control, results in decreased pain and/or narcotic use at time points ranging from perioperative to six months post discharge. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Assessment of post-thoracotomy pain | Visual Analog Scale will be used to assess pain levels (0-10 range scale with 0=no pain and 10= worse pain ever | 6 months | 
| Quality of Life (SF-36) changes from baseline to 6-months | Assessment of the impact of pain on quality of life (questions using varied assessment scales: rating general health from excellent to poor; yes-no; none to very severe; not at all to extremely; all of the time to none of the time; true-false | 6 months | 
| Allodynia Assessment | Allodynia screening and assessments will assess the levels of skin hypersensitivity associated with neuropathic pain following thoracotomy and will be performed at predetermined time points | 6 months | 
| Mankoski Pain Scale Assessment of post-thoracotomy pain | Mankoski Pain Scale will be used to assess pain levels (scale ranging from 0 to 10 with 0 = no pain to 10 = worse pain ever | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryoanalgesia, Thoracotomy, Pain