Chronic Post-thoracotomy Pain, Acute Post-thoracotomy Pain, Post-thoracotomy Pain Syndrome
Conditions
Keywords
Thoracotomy, Cryoanalgesia, Pain
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.
Interventions
PROCEDUREThoracic Epidural
The control arm will receive standard of care pain management which includes a Thoracic Patient Controlled Epidural
PROCEDUREIntercostal Cryoanalgesia
The study arm will receive standard of care pain management which includes a Thoracic Epidural plus Intraoperative Intercostal Cryoanalgesia
Sponsors
AtriCure, Inc.
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total narcotic use post-thoracotomy. | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Assessment of post-thoracotomy pain | 6 months | Visual Analog Scale will be used to assess pain levels (0-10 range scale with 0=no pain and 10= worse pain ever |
| Quality of Life (SF-36) changes from baseline to 6-months | 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 |
| Allodynia Assessment | 6 months | 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 |
| Mankoski Pain Scale Assessment of post-thoracotomy pain | 6 months | 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 |
Countries
United States
Contacts
Primary ContactMelissa Culligan, RN, MS
Outcome results
None listed