Cryotherapy Effect, Pain, Postoperative
Conditions
Keywords
pulmonary, resection, cryotherapy
Brief summary
This is a research study designed to test whether a treatment called Intercostal Nerve Cryotherapy is an effective way to help control post-surgical pain for patients undergoing minimally invasive pulmonary resection. There are two treatment groups in this study, a cryotherapy group and control group. Cryotherapy is a method of controlling pain by freezing nerves between the ribs that would transmit pain impulses to the brain.
Interventions
DEVICEcryoanalgesia
intraoperative intercostal nerve freezing for post-operative pain control
OTHERStandard of Care Pain Control
Standard of Care Pain Control Post-operatively
Sponsors
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
AtriCure, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
participants will be blinded to treatment group and will be sedated (part of standard of care surgery) at the time the treatment occurs
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients 18 year and older. 2. Undergoing elective minimally invasive (VATS or robotic) lung resection for nodules (wedge resection, segmentectomy, lobectomy). 3. Performance status of 1 or 2.
Exclusion criteria
1. Patients with ejection fraction less than 40% 2. Patients with creatinine greater than 1.5. 3. Patients with Child's B or C cirrhosis 4. Patients on chronic narcotics for other reasons 5. Patients diagnosed with fibromyalgia 6. Patients who had previous thoracic surgery on the same side. 7. Patients who cannot communicate in English. 8. Patients unable to provide informed consent for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine dose | to discharge (up to 14 days) | total milligrams (mg) of morphine received during hospitalization |
| Pain control | to discharge (up to 14 days) | Pain level, as assessed by visual analog scale (rating 0-10), with 0 being no pain to 10 being worst pain, with higher scores meaning a worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| pulmonary complications | through 1 year | Pulmonary complications as defined by the Society of Thoracic Surgeons database |
| pain control | 2 weeks and 3 months post-operatively | Pain level, as assessed by visual analog scale (rating 0-10), with 0 being no pain to 10 being worst pain, with higher scores meaning a worse outcome |
| total morphine equivalent dose of narcotics | 2 weeks and 3 months post-operatively | total dose (e.g. milligrams) assessed by the number of pills taken by patients postoperatively |
| Presence of neuropathy in the surgical site | 2 weeks, 3 months, 6 months and 1 year postoperatively | physician will assess by modified treatment-induced neuropathy scale (0-10), with higher scores meaning a worse outcome; The modified questionnaire will assess the following symptoms and ask patients to score those symptoms from 0 (not present) to 10 (unbearable): * Numbness at or near the incision site (including chest wall) * Tingling at or near the incision site * Pain at or near the incision site * Hot or burning sensation at or near the incision site * Feeling of coldness at or near the incision site |
| Incentive Spirometer Volume | to discharge (up to 14 days) | The highest number (breath volume) achieved on exhalation using the incentive spirometer |
| Hospital length of stay | to discharge (up to 14 days) | Number of days spent in hospital postoperatively |
Countries
United States
Outcome results
None listed