Status:
UNKNOWN
Hepatic Hilar Nerve Block Versus Sham in Pain Control During Liver Ablation and TACE Procedures
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Pain Control
Liver Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This study is aimed at assessing the effectiveness of a novel liver specific nerve block in improving pain control during painful liver interventional radiology procedures including liver tumoral abla...
Detailed Description
This is a prospective study. Experienced interventional radiologists in the two McGill University Health Centre study centers (Royal Victoria Hospital and Montreal General Hospital) will perform all p...
Eligibility Criteria
Inclusion
- Patients referred to the Interventional Radiology department and approved for a chemo-embolization or radiofrequency ablation of malignant primary or secondary liver tumour.
- At least 18 y.o.
Exclusion
- Patients in whom the vascular anatomy prevents safe access to the hepatic hilum or patients in whom general anaesthesia was performed.
- Patients who have known allergy to any anaesthetic agent in the regular protocol (fentanyl, midazolam, ropivacaine).
- Patients with signs of skin infection at the entry site of the needle used to perform the nerve block
- Patients with signs of infection such as fever or acute increase in wight blood cell count.
- Patients with uncorrectable abnormal coagulation status (INR \>1.5 and platelets \< 50000 without use of anticoagulation agents).
- Patients with pre-existing conditions, which, in the opinion of the investigator, interfere with the conduct of the study (these reasons will be recorded)
- Patients, who are uncooperative, cannot follow instructions, or who are unlikely to comply with follow-up appointments or fill-out the post-procedural pain questionnaires.
- Patients with a mental state that may preclude completion of the study procedure or are unable to provide informed consent.
Key Trial Info
Start Date :
November 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04769713
Start Date
November 23 2021
End Date
September 30 2023
Last Update
June 2 2023
Active Locations (1)
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1
McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1