N/A
N=84
The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)
Pain
Bottom Line
View on ClinicalTrials.gov: NCT02922153 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery — 1.2; 0.93 Liters (L) — p=0.0223
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cryoanalgesia (Device); Standard of Care (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AtriCure, Inc.
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery |
1.2; 0.93 | 0.0223 sig |
| PRIMARY Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery |
2.82; 3.06 | 0.6259 |
| SECONDARY Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation |
1.20; 0.93; 1.60; 1.33; 1.52; 1.28 | 0.0201 sig |
| SECONDARY Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points |
2.08; 1.44; 1.84; 2.00; 2.50; 2.40 | 0.3085 |
| SECONDARY Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit |
0; 0; 1; 0 | — |
| SECONDARY Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room |
8.85; 7.33 | 0.4421 |
| SECONDARY Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points |
11.43; 17.32; 20.91; 31.05; 14.87; 16.67 | 0.4352 |
| SECONDARY Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge |
4.96; 2.96; 9.40; 6.32 | 0.2939 |
| SECONDARY Secondary Outcome 7: Ambulatory Movement During Hospital Stay |
65; 19; 0; 0; 0; 0 | 0.2877 |
Summary
The investigators propose to assess whether intra-operative intercostal cryoanalgesia using the cryoICE® probe (AtriCure®, Inc., 7555 Innovation Way, Mason, Ohio) provides superior post-operative analgesic efficacy as compared to current pain management in patients undergoing unilateral thoracotomy cardiac procedures.
Eligibility Criteria
Inclusion Criteria
- Age 18 - 85 years male or female
- Patients undergoing unilateral thoracotomy cardiac procedures (with the exception of Aortic Aneurysm repair as sole treatment)
- 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
- Cardiac valve surgical procedure via conventional full sternotomy
- Procedures that require a posterolateral thoracotomy
- Current pregnancy
- Current use of prescription opioids
- FEV1 < 40% predicted
- Documented myocardial infarction within 30 days of signing Informed Consent Form (ICF)
- Documented psychiatric disease
- Documented chronic pain syndrome
- Documented history of substance abuse
- Patient 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
- Disqualifying medical condition per investigator
Data sourced from ClinicalTrials.gov (NCT02922153). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.