The main objective study is to compare the use of the cryoSPHERE probe to the standard-of-care method for pain management of patients receiving robotic-assisted thoracoscopic surgery, including reductions in opioid pain medication use and the development of post-surgical morbidity.
Patients who take more opioid medications after surgery tend to have longer hospital stays, and they are at risk of developing pneumonia and other postoperative morbidities. Opioid-tolerant patients are at a higher risk of developing these morbidities because they often require higher doses of opioid medications to manage their post-operative pain. Reducing post-operative pain in these patients through non-opioid means helps reduce their risk of developing morbidities, and is potentially a more effective form of pain management, particularly in this patient population. This is a single-center, prospective cohort registry with a historical control, and an estimated duration of 2 years. This study's primary objective is to evaluate the cryoSPHERE probe for ablation in pain control after surgery (measured using opioid medication). The secondary objectives are the evaluation of morbidities, length of stay, cost, and incidence of neuroma formation. We plan to recruit 75 patients who will receive the cryoSPHERE probe and compare them to 75 patients who did not receive the cryoSPHERE probe. The experimental group will receive cryoSPHERE ablation of intercostal nerves and liposomal bupivacaine. The historical control group will have had robotic-assisted thoracoscopic surgery and an intercostal nerve block with liposomal bupivacaine and no cyroSPHERE probe.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
The cryoSPHERE probe will be introduced through a thoracoscopic port and placed inferior to each rib level and 2cm lateral and away from the sympathetic chain when clearly visible or 4cm lateral and away from the spine when the sympathetic chain is not visible. Levels to be ablated are intercostal spaces 3-9. Each intercostal nerve will undergo cryogenic ablation of -70 degrees Celsius for 120 seconds. The probe will be firmly pushed against the nerve for 120 seconds and will only be released from the nerve when the probe has thawed. Axons within the intercostal nerve that send pain signals will be destroyed distal to the cryoablation site. However, the tubules structures (epineurium, perineurium, and endoneurium) of the nerve will remain intact, allowing the axons to regenerate and nerve function to resume after one to three months.
A long needle will be introduced through a thoracoscopic port, and in each intercostal space (1-11), 1ml of liposomal bupivacaine will be injected onto the intercostal nerves to induce intercostal nerve blockage.
Houston Methodist Research Institute
Houston, Texas, United States
Opioid Use Within 24 Hours After Chest Tube Removal
Opioid use measured as the daily dose of milligram morphine equivalents (MME)
Time frame: From the time of chest tube removal to 24 hours after chest tube removal
Total Emergent Adverse Effects (TEAE)
Morbidity, defined as total emergent adverse effects (TEAE) for the experimental group vs. control
Time frame: Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery
Length of Hospital Stay
Time spent in the hospital from admission for surgery until discharge or death
Time frame: From admission to discharge or death, up to 1 year after surgery
Mean Cost of Hospital Care
Total cost of billed medical care for the surgery
Time frame: From admission to discharge or death, up to 1 year after surgery
Number of Readmissions
The number of readmissions to the hospital
Time frame: From initial admission for surgery to 28 days after surgery
Neuroma Formation
The formation of a neuroma around the site of nerve block administration
Time frame: Time of discharge (up to 1 year after surgery), 3 months after surgery, and 6 months after surgery
Pain Score
Patient's perceived pain level on a scale of 1 to 10
Time frame: Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery
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PROMIS3a Pain Intensity
Patient's perceived pain level on a scale of 3-15, per PROMIS Pain Intensity Short Form 3a v1.0
Time frame: Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery
PROMIS8a Pain Interference
Patient's perceived pain interference level on a scale of 8-40, per PROMIS Pain Interference Adult Form
Time frame: Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery
Opioid Use after Surgery
Mean daily opioid use after surgery measured in milligram morphine equivalents (MME)
Time frame: Day 1 after surgery, day 3 after surgery, 5 weeks after surgery, 3 months after surgery