The ICE Study study will compare standard therapy (thoracic epidural) versus a novel approach (Cryoanalgesia combined with thoracic epidural) in subjects undergoing unilateral thoracotomy.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
138
The control arm will receive standard of care pain management which includes a Thoracic Patient Controlled Epidural
The study arm will receive standard of care pain management which includes a Thoracic Epidural plus Intraoperative Intercostal Cryoanalgesia
University of Maryland Medical Center
Baltimore, Maryland, United States
RECRUITINGTotal 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.
Time frame: 6 months
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.