Intrathoracic Procedure, Pain, Postoperative
Conditions
Brief summary
The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.
Interventions
DEVICEAtricure's crysoSPHERE probe
Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas.
PROCEDUREStandard of Care
An intercostal nerve block involves injecting anesthetic medications into nerves around the thoracic incision to provide temporary longer term pain relief after surgery.
Sponsors
AtriCure, Inc.
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients who could receive cryoablation in an elective open thoracic (posterolateral thoracotomy) or minimally invasive (thoracoscopy, including robotic) procedures at Michigan Medicine * Patient is opioid naïve
Exclusion criteria
* Patients who are pregnant * Patients with cognitive impairment * Patients with psychological disorders * Patients with prior thoracic surgery * Patients with fibromyalgia * Patients with redo ipsilateral thoracic surgery * Patients undergoing bilateral thoracotomy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of pain in the peri-operative period | Post-op day 1 and day of hospital discharge, approximately 3 days | Pain measured using a numeric rating scale ranging from 1-10 where a higher pain score indicates more pain severity |
| Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) | baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop | assessment of feeling or touching sensations along the thoracic cavity measured using dermatone assessment |
| Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy) | baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop | Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity surveys |
| Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score | Pre-surgery, 6-hours after end of surgery and 24-hours after surgery | Correlations with the pain scores from outcome #1 |
| Inflammatory cytokine levels as measured by blood samples | Pre-surgery, 6-hours after end of surgery and 24-hours after surgery | Levels are measured using blood sample collection and assay specifically assessing IL-1, IL-6, TNF-a |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score as measured by SF-36 Health questionnaire | baseline (prior to surgery), day of hospital discharge, approximately 3 days, 30-days, 90-days and 180-days post-op. | 36 item survey instrument |
| Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management) | Up to 180-days postop | Hospital charges for cases that get standard of care postop pain management versus cases that receive cryoablation. |
| Workflow/time | Up to 180-days postop | Including items such as length of operating room use and length of hospital stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| Complications following surgery | Up to 180-days following surgery | Any unexpected or unanticipated incidents, symptoms or medical issues following surgery |
| Time to ambulation | Up to 180-days following surgery | Day of first ambulation documented |
| Length of stay | Up to hospital discharge, approximately 3 days | length of hospital stay |
| Incentive spirometry volumes in the peri-operative period (POD 1 and 2) | Postop day 1 and 2 | — |
| Chronic pain through 6 months. | Up to 180-days after surgery | Chronic pain is defined as pain that lasts for over three months as assessed by the PROMIS Pain Intensity survey |
| Chronic Pain medication use through 6 months | Up to 180-days after surgery | — |
| Oxygen requirement | Up to 180-days postop | documentation of oxygen use |
| Hospital charges and hospital reimbursement by different payors | Up to 180-days postop | — |
Countries
United States
Contacts
Primary ContactShari L Barnett
Outcome results
None listed