The cryoICE™ CryoAnalgesia Study For Pain Management in Post thoRacic Procedures Via intercOSTal Cryoanalgesia (FROST)

Not Applicable

Completed

Conditions: Pain

Interventions: Device: Cryoanalgesia
Drug: Standard of Care

Registration Number: NCT02922153

Lead Sponsor: AtriCure, Inc.

Brief 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.

Detailed Description: Completion of the proposed study will for the first time demonstrate efficacy of intercostal cryoanalgesia in patients undergoing minimally invasive cardiac procedures. Furthermore, results of this study may have a pivotal role in supporting future clinical outcome trials for intercostal cryoanalgesia therapy.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 84

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cryoanalgesia + Standard of Care (SOC)	Cryoanalgesia	Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.
Cryoanalgesia + Standard of Care (SOC)	Standard of Care	Cryoanalgesia in Conjunction with Standard of Care. Up to 5 sessions of cryoanalgesia for 120 seconds per session.
Standard of Care	Standard of Care	Institutional SOC for pain management will be followed. The use of local post-operative pain management techniques (i.e., intercostal, peri-vertebral, or any other acceptable method) is permitted for both treatment groups up to 24 hours post-operatively according to institutional standard of care.

Primary Outcome Measures

Name	Time	Method
Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery	48-hours post-surgery	Forced Expiratory Volume (FEV1) is the measurement of how much air, in volume, that a person can exhale with a forced breath. It is measured using a spirometer device.
Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery	48-hours post-surgery	The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically.

Secondary Outcome Measures

Name	Time	Method
Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation	48-hours post-extubation	Spirometry assessments measured included: forced expiratory volume (FEV1), forced vital capacity (FVC) and slow vital capacity (SVC), all of which are measured with a spirometer. FEV1 is the amount of air forcibly expired during the first second of breath, FVC is the total volume of air expired over the whole forced breath and SVC is the total volume over the whole breath but at a slow pace, not forced.
Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points	72-, 96- and 120-hours Post-Op	The Visual Analogue Scale (VAS) uses a picture of a linear scale that shows numbers 0-10 with 0 being the least amount of pain and 10 being the most amount of pain. This outcome looked at pain in the surgical region specifically.
Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit	3 and 6 Months	Allodynia is pain around surgical site. It is pain that occurs from stimuli that are not normally painful such as a light touch or a brush of hair around where the surgery took place.
Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room	Hours until patient is extubated from time patient leaves the operating room	Oral endotracheal intubation is where a patient has a tube placed down their throat and into the trachea, the large airway from the mouth to the lungs. This is done to ensure that patients who are asleep under anesthesia are able to fully breath. This outcome measured the hours from the time the patient leaves the operating room until they were extubated, or had the tube removed from their trachea.
Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge	Procedure to Discharge	The outcome measures the time spent in the intensive care unit (ICU) as well as the total hospital length of stay.
Secondary Outcome 7: Ambulatory Movement During Hospital Stay	Baseline, 48, 72, 96, 120 Hours and Discharge	Ambulatory Movement, defined as the subjects ability to sit up, stand up, walk and flex both the left and right shoulders, was measured at multiple time points during hospital stay.
Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points	24-, 48, -96 and 120-hours	Patient Controlled Analgesia (PCA) is when the patient chooses to give themselves some form of analgesia, or painkiller, depending on their post-operation pain levels. Oral opioid consumption is the measure of all painkiller medicine that was prescribed by the hospital to the patient to take. This outcome measures each of these up to each time point and also measures the total PCA and oral opioid consumption post-procedure for the whole hospital stay.

Trial Locations

Locations (5): University of Southern California (USC)
🇺🇸
Los Angeles, California, United States
University of Michigan
🇺🇸
Ann Arbor, Michigan, United States
William Beaumont Hospital
🇺🇸
Royal Oak, Michigan, United States
United Heart and Vascular Institute - Allina
🇺🇸
Saint Paul, Minnesota, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States