Trials / Unknown
UnknownNCT03538340
Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy
Randomized, Single-Blinded, Controlled Trial Using Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy: ICE Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- Sponsor
- University of Maryland, Baltimore · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2018-09-01
- Primary completion
- 2022-12-31
- Completion
- 2023-01-31
- First posted
- 2018-05-29
- Last updated
- 2021-04-27
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03538340. Inclusion in this directory is not an endorsement.