Intercostal Nerve Cryotherapy in Patients Undergoing Minimally Invasive Pulmonary Resection
- Conditions
- Cryotherapy EffectPain, Postoperative
- Interventions
- Device: cryoanalgesiaOther: Standard of Care Pain Control
- Registration Number
- NCT05348447
- Lead Sponsor
- Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 110
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cryoanalgesia with standard of care pain control cryoanalgesia subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery Cryoanalgesia with standard of care pain control Standard of Care Pain Control subjects will receive standard of care pain control + cryoanalgesia in the intercostal spaces during routine surgery Standard of care pain control Standard of Care Pain Control subjects will receive standard of care pain control only
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method pulmonary complications through 1 year Pulmonary complications as defined by the Society of Thoracic Surgeons database
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
Incentive Spirometer Volume to discharge (up to 14 days) The highest number (breath volume) achieved on exhalation using the incentive spirometer
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
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 siteHospital length of stay to discharge (up to 14 days) Number of days spent in hospital postoperatively
Trial Locations
- Locations (1)
AHN Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States