Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

A Randomized Controlled Trial of cryoSPHERE (CRYOS/CRYOS-L) Ablation of Intercostal Nerves for Post-Operative Pain Management in Opioid-Tolerant Patients Undergoing Robotic-Assisted Thoracoscopic Surgery

ID
Name
PRO00029370
Description
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.
Trial arms
Trial start
2023-02-01
Estimated PCD
2025-03-15
Trial end
2025-09-15
Treatment
cryoSPHERE Ablation
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.
Arms:
Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation
Other names:
cryoSPHERE
Bupivacaine
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.
Arms:
Historical Controls, Nerve Block Using Liposomal Bupivacaine and cryoSPHERE Ablation
Other names:
liposomal bupivacaine, Exparel
Size
75
Primary endpoint
Opioid Use Within 24 Hours After Chest Tube Removal
From the time of chest tube removal to 24 hours after chest tube removal
Eligibility criteria
Inclusion Criteria: * 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 Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}
Updated at
2023-03-24

1 organization

1 product

2 indications

Organization
Methodist Hospital Research Institute
Product
Bupivacaine
Indication
Pain
Indication
Postoperative