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Local Anesthetic

Hepatic hilar nerve block in ablation patients for Pain Management

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4-6 weeks for reporting.

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 more

Secondary 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 more

Awards & 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

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