Status:
UNKNOWN
Cryoablation of Intercostal Nerves for Post-Operative Pain Management in Opioid-Tolerant Patients
Lead Sponsor:
The Methodist Hospital Research Institute
Conditions:
Pain
Pain, Postoperative
Eligibility:
All Genders
18-90 years
Phase:
NA
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 reduct...
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 a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
February 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT05276258
Start Date
February 1 2023
End Date
September 15 2025
Last Update
March 24 2023
Active Locations (1)
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1
Houston Methodist Research Institute
Houston, Texas, United States, 77030