Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Trial of Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection

Conditions
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Cryotherapy Effect, Pain, Postoperative

Intervention / Treatment
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* Device: cryoanalgesia
* Other: Standard of Care Pain Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 18 year and older. Undergoing elective minimally invasive (VATS or robotic) lung resection for nodules (wedge resection, segmentectomy, lobectomy). Performance status of 1 or 2. Exclusion Criteria: Patients with ejection fraction less than 40% Patients with creatinine greater than 1.5. Patients with Child's B or C cirrhosis Patients on chronic narcotics for other reasons Patients diagnosed with fibromyalgia Patients who had previous thoracic surgery on the same side. Patients who cannot communicate in English. Patients unable to provide informed consent for the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryoanalgesia with standard of care pain control<br>subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery | Device: cryoanalgesia<br>* intraoperative intercostal nerve freezing for post-operative pain control<br>Other: Standard of Care Pain Control<br>* Standard of Care Pain Control Post-operatively<br>|
| Active Comparator: Standard of care pain control<br>subjects will receive standard of care pain control only | Other: Standard of Care Pain Control<br>* Standard of Care Pain Control Post-operatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total morphine dose | total milligrams (mg) of morphine received during hospitalization | to discharge (up to 14 days) | 
| Pain control | 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 | to discharge (up to 14 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary complications | Pulmonary complications as defined by the Society of Thoracic Surgeons database | through 1 year | 
| pain control | 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 | 2 weeks and 3 months post-operatively | 
| total morphine equivalent dose of narcotics | total dose (e.g. milligrams) assessed by the number of pills taken by patients postoperatively | 2 weeks and 3 months post-operatively | 
| Presence of neuropathy in the surgical site | 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 | 2 weeks, 3 months, 6 months and 1 year postoperatively | 
| Incentive Spirometer Volume | The highest number (breath volume) achieved on exhalation using the incentive spirometer | to discharge (up to 14 days) | 
| Hospital length of stay | Number of days spent in hospital postoperatively | to discharge (up to 14 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulmonary, resection, cryotherapy