Cryoablation of Intercostal Nerves for Post-Operative Pain Management in Opioid-Tolerant Patients
- Conditions
- PainPain, Postoperative
- Interventions
- Device: cryoSPHERE Ablation
- Registration Number
- NCT05276258
- Lead Sponsor
- The Methodist Hospital Research Institute
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 75
- Male and female patients 18-90 years of age
- Diagnosis requiring robotic-assisted thoracoscopic surgery
- Daily opioid use for at least 30 days consecutively at any point during the last 12 months prior to surgery or using opioids at the time of study enrollment
- Experimental group only: agreement and consent to comply with all aspects of the study protocol and data collection, including follow-up contact.
- Previous major surgery at the operative site (thoracotomy)
- Allergy to aluminum
- Allergy to plastics
- Allergy to bupivacaine
- Shingles disease
- Demyelinating illnesses
- Involvement with other interventional studies
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation cryoSPHERE Ablation The experimental group (75 participants) will undergo intercostal nerve block using liposomal bupivacaine and the cryoSPHERE ablation of intercostal nerves during robotic-assisted thoracoscopic operation at Houston Methodist Hospital. Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation Bupivacaine The experimental group (75 participants) will undergo intercostal nerve block using liposomal bupivacaine and the cryoSPHERE ablation of intercostal nerves during robotic-assisted thoracoscopic operation at Houston Methodist Hospital. Historical Controls Bupivacaine A total of 75 propensity score-matched historical controls will be selected from the pool of patients who had standard intercostal nerve block using liposomal bupivacaine alone at Houston Methodist Hospital from January 1, 2017 through January 1, 2022, inclusively.
- Primary Outcome Measures
Name Time Method Opioid Use Within 24 Hours After Chest Tube Removal From the time of chest tube removal to 24 hours after chest tube removal Opioid use measured as the daily dose of milligram morphine equivalents (MME)
- Secondary Outcome Measures
Name Time Method Total Emergent Adverse Effects (TEAE) Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery Morbidity, defined as total emergent adverse effects (TEAE) for the experimental group vs. control
Opioid Use after Surgery Day 1 after surgery, day 3 after surgery, 5 weeks after surgery, 3 months after surgery Mean daily opioid use after surgery measured in milligram morphine equivalents (MME)
Mean Cost of Hospital Care From admission to discharge or death, up to 1 year after surgery Total cost of billed medical care for the surgery
PROMIS8a Pain Interference Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery Patient's perceived pain interference level on a scale of 8-40, per PROMIS Pain Interference Adult Form
Number of Readmissions From initial admission for surgery to 28 days after surgery The number of readmissions to the hospital
Length of Hospital Stay From admission to discharge or death, up to 1 year after surgery Time spent in the hospital from admission for surgery until discharge or death
Neuroma Formation Time of discharge (up to 1 year after surgery), 3 months after surgery, and 6 months after surgery The formation of a neuroma around the site of nerve block administration
Pain Score Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery Patient's perceived pain level on a scale of 1 to 10
PROMIS3a Pain Intensity Time of discharge (up to 1 year after surgery), 5 weeks after surgery, 3 months after surgery, and 6 months after surgery Patient's perceived pain level on a scale of 3-15, per PROMIS Pain Intensity Short Form 3a v1.0
Trial Locations
- Locations (1)
Houston Methodist Research Institute
🇺🇸Houston, Texas, United States