Liver Cancer Clinical Trial
Official title:
Prospective Randomized Double-Blind Study of Pain Control With Hepatic Hilum Nerve Block Versus Sham Procedure For Hepatic Chemoembolization or Radiofrequency Ablation
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 ablation and trans arterial chemoembolization, two procedures aimed at controlling liver tumors, but that can be associated with significant pain. This novel hepatic specific nerve block was designed by us and initial retrospective results suggests it might help in controlling such liver procedural derived pain. The study was designed to compare the liver block to a sham procedure in a blinded context and to follow the participants over three days post-procedure to asses for pain levels.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | September 30, 2023 |
Est. primary completion date | June 30, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Patients referred to the Interventional Radiology department and approved for a chemo-embolization or radiofrequency ablation of malignant primary or secondary liver tumour. 2. At least 18 y.o. Exclusion Criteria: 1. Patients in whom the vascular anatomy prevents safe access to the hepatic hilum or patients in whom general anaesthesia was performed. 2. Patients who have known allergy to any anaesthetic agent in the regular protocol (fentanyl, midazolam, ropivacaine). 3. Patients with signs of skin infection at the entry site of the needle used to perform the nerve block 4. Patients with signs of infection such as fever or acute increase in wight blood cell count. 5. Patients with uncorrectable abnormal coagulation status (INR >1.5 and platelets < 50000 without use of anticoagulation agents). 6. Patients with pre-existing conditions, which, in the opinion of the investigator, interfere with the conduct of the study (these reasons will be recorded) 7. 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. 8. Patients with a mental state that may preclude completion of the study procedure or are unable to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
Canada | McGill University Health Centre | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
McGill University Health Centre/Research Institute of the McGill University Health Centre |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in pain after a hepatic hilar nerve block during and immediately after liver ablation | Visual analog pain score will be compared between patient having received the hepatic hilar nerve block versus those having had a placebo procedure done during the ablation procedure and while in post-anesthetic care unit. Visual analog scales are on a scale of 0-10 with 0 being no pain and 10 the worse pain imaginable. | 1 day | |
Primary | Changes in narcotic use after a hepatic hilar nerve block during and immediately after liver ablation | Number of mg of narcotics used to control the pain during and immediately after the ablation while in post-anesthetic care unit will be compared between the group having had the hepatic hilar nerve block and those having had the placebo | 1 day | |
Primary | Changes in pain after a hepatic hilar nerve block during and immediately after liver chemoembolization | Visual analog pain score will be compared between patient having received the hepatic hilar nerve block versus those having had a placebo procedure done during the chemoembolization procedure and while in post-anesthetic care unit. Visual analog scales are on a scale of 0-10 with 0 being no pain and 10 the worse pain imaginable. | 1 day | |
Primary | Changes in narcotic use after a hepatic hilar nerve block during and immediately after liver chemoembolization | Number of mg of narcotics used to control the pain during and immediately after the chemoembolization while in post-anesthetic care unit will be compared between the group having had the hepatic hilar nerve block and those having had the placebo | 1 day | |
Secondary | Changes in pain after a hepatic hilar nerve block in the early days following liver ablation | Visual analog pain score will be compared between patient having received the hepatic hilar nerve block versus those having had a placebo procedure done up to 3 days post ablation. Visual analog scales are on a scale of 0-10 with 0 being no pain and 10 the worse pain imaginable. | 3 days | |
Secondary | Changes in narcotic use after a hepatic hilar nerve block in the early days after liver ablation | Number of mg of narcotics used to control the pain in the next 3 days after the ablation while in post-anesthetic care unit will be compared between the group having had the hepatic hilar nerve block and those having had the placebo | 3 days | |
Secondary | Changes in pain after a hepatic hilar nerve block in the early days following liver chemoembolization | Visual analog pain score will be compared between patient having received the hepatic hilar nerve block versus those having had a placebo procedure done up to 3 days post chemoembolization. Visual analog scales are on a scale of 0-10 with 0 being no pain and 10 the worse pain imaginable. | 3 days | |
Secondary | Changes in narcotic use after a hepatic hilar nerve block in the early days after liver chemoembolization | Number of mg of narcotics used to control the pain in the next 3 days after the chemoembolization while in post-anesthetic care unit will be compared between the group having had the hepatic hilar nerve block and those having had the placebo | 3 days | |
Secondary | Changes in anti-nausea medication use after a hepatic hilar nerve block during and immediately after liver ablation | Number of mg of anti-nausea medication used to control the pain during and immediately after the ablation while in post-anesthetic care unit will be compared between the group having had the hepatic hilar nerve block and those having had the placebo | 1 day | |
Secondary | Changes in anti-nausea medication use after a hepatic hilar nerve block during and immediately after liver chemoembolization | Number of mg of anti-nausea medication used to control the pain during and immediately after the chemoembolization while in post-anesthetic care unit will be compared between the group having had the hepatic hilar nerve block and those having had the placebo | 1 day | |
Secondary | Incidence of complications secondary to performing the hepatic hilar nerve block | Incidence of complications (graded based on society of interventional radiology complication grading system) will be calculated for the various grades | 4-6 weeks | |
Secondary | Differences in disease response post liver tumoral ablation between patients with hepatic hilar nerve block and those with sham procedure | RECIST criteria scoring system will be used to compare treatment response on CT/MRI 4-6 weeks post liver tumoral ablation in patients having had the hepatic hilar block versus those having had the sham procedure | 4-6 weeks | |
Secondary | Differences in disease response post liver tumoral chemoembolization between patients with hepatic hilar nerve block and those with sham procedure | RECIST criteria scoring system will be used to compare treatment response on CT/MRI 4-6 weeks post liver tumoral chemoembolization in patients having had the hepatic hilar block versus those having had the sham procedure | 4-6 weeks |
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