Randomized Trial of Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection
Overview
- Phase
- N/A
- Intervention
- cryoanalgesia
- Conditions
- Cryotherapy Effect
- Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Total morphine dose
- Status
- Active, Not Recruiting
- Last Updated
- 2 months ago
Overview
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.
Investigators
Benny Weksler, MD
System Chief of Thoracic Surgery
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Eligibility Criteria
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.
- •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.
Arms & Interventions
Cryoanalgesia with standard of care pain control
subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery
Intervention: cryoanalgesia
Cryoanalgesia with standard of care pain control
subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery
Intervention: Standard of Care Pain Control
Standard of care pain control
subjects will receive standard of care pain control only
Intervention: Standard of Care Pain Control
Outcomes
Primary Outcomes
Total morphine dose
Time Frame: to discharge (up to 14 days)
total milligrams (mg) of morphine received during hospitalization
Pain control
Time Frame: 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 Outcomes
- pulmonary complications(through 1 year)
- total morphine equivalent dose of narcotics(2 weeks and 3 months post-operatively)
- Incentive Spirometer Volume(to discharge (up to 14 days))
- pain control(2 weeks and 3 months post-operatively)
- Presence of neuropathy in the surgical site(2 weeks, 3 months, 6 months and 1 year postoperatively)
- Hospital length of stay(to discharge (up to 14 days))