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Local Anesthetic
Hepatic Hilar Nerve Block Versus Sham in Pain Control During Liver Ablation and TACE Procedures
Phase 4
Recruiting
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-6 weeks
Awards & highlights
Approved for 5 Other Conditions
Pivotal Trial
All Individual Drugs Already Approved
Drug Has Already Been Approved
Summary
This trial tests a special injection to numb liver nerves and reduce pain in patients undergoing painful liver tumor treatments. The injection uses a medication to numb the nerves around the liver, helping to lessen pain during and after the procedures.
Eligible Conditions
- Hepatocellular Carcinoma
- Pain Management
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in narcotic use after a hepatic hilar nerve block during and immediately after liver ablation
Changes in narcotic use after a hepatic hilar nerve block during and immediately after liver chemoembolization
Changes in pain after a hepatic hilar nerve block during and immediately after liver ablation
+1 moreSecondary study objectives
Changes in anti-nausea medication use after a hepatic hilar nerve block during and immediately after liver ablation
Changes in anti-nausea medication use after a hepatic hilar nerve block during and immediately after liver chemoembolization
Changes in narcotic use after a hepatic hilar nerve block in the early days after liver ablation
+6 moreAwards & Highlights
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Hepatic hilar nerve block in chemoembolization patientsExperimental Treatment2 Interventions
15ml of 0.7% ropivacaine will be injected at the hepatic hilum anterior to the portal vein as close to the bifurcation as possible under US guidance using a 21g needle prior to the chemoembolization procedure.
Group II: Hepatic hilar nerve block in ablation patientsExperimental Treatment2 Interventions
15ml of 0.7% ropivacaine will be injected at the hepatic hilum anterior to the portal vein as close to the bifurcation as possible under US guidance using a 21g needle prior to the Ablation procedure.
Group III: Placebo procedure in ablation patientsPlacebo Group2 Interventions
15ml of sterile normal saline will be injected at the hepatic hilum anterior to the portal vein as close to the bifurcation as possible under US guidance using a 21g needle prior to the Ablation procedure.
Group IV: Placebo procedure in chemoembolization patientsPlacebo Group2 Interventions
15ml of sterile normal saline will be injected at the hepatic hilum anterior to the portal vein as close to the bifurcation as possible under US guidance using a 21g needle prior to the chemoembolization procedure.
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Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
470 Previous Clinical Trials
166,864 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Hepatic hilar nerve block in ablation patients
- Group 2: Placebo procedure in ablation patients
- Group 3: Hepatic hilar nerve block in chemoembolization patients
- Group 4: Placebo procedure in chemoembolization patients
Awards:
This trial has 4 awards, including:- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.