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Completed

NCT Number: NCT02922153

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

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Southern California (USC), Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cryoanalgesia

Device

AtriCure® cryoICE cryo-ablation system

Other names: cryoICE

Standard of care

Drug

Institutional SOC for pain management will be followed.

Other names: SOC

Primary outcomes

  1. Primary Outcome 1: Forced Expiratory Volume (FEV1) at 48-Hours Post-Surgery

    Time frame: 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.

  2. Primary Outcome 2: Visual Analogue Scale (VAS) Pain in the Surgical Region at 48-Hours Post-Surgery

    Time frame: 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 outcomes

  1. Secondary Outcome 1: Spirometry Assessments at 48-Hours Post-Extubation

    Time frame: 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.

  2. Secondary Outcome 2: Visual Analogue Scale (VAS) Pain at the 72, 96 and 120-Hours Post-Op Time Points

    Time frame: 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.

  3. Secondary Outcome 3: Allodynia at the 3 and 6 Month Visit

    Time frame: 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.

  4. Secondary Outcome 4: Duration of Oral Endotracheal Intubation From Extubation Until the Patient Leaves the Operating Room

    Time frame: 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.

  5. Secondary Outcome 5: Patient Controlled Analgesia (PCA) and Oral Opioid Consumption at the 24, 48, 96 and 120 Hour Time Points

    Time frame: 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.

  6. Secondary Outcome 6: ICU and Hospital Length of Stay From Procedure to Discharge

    Time frame: Procedure to Discharge

    The outcome measures the time spent in the intensive care unit (ICU) as well as the total hospital length of stay.

  7. Secondary Outcome 7: Ambulatory Movement During Hospital Stay

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AtriCure, Inc.

Industry

Registry information

Acronym: FROST

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 4, 2016
Registry last updated
Sep 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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