Neoplasms

Digestive System Diseases

All Conditions

Symptoms and General Pathology

Liver Neoplasms

Pain

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Antineoplastic Agents

Hematinics

Ropivacaine

Chlorotrianisene

Liver Extracts

Anesthetics

Anesthetics, Local

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.

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.

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.

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.

Placement of a needle within 2cm of the portal vein bifurcation along its anterior surface for injection of nerve block agent (for nerve block) or saline (placebo) under US or CT guidance.

Hepatic Hilar Nerve Block Needle placement

Injection of 15 ml 0.5% Ropivacaine at the hepatic hilum along the anterior surface of the portal vein within 2cm of the bifurcation.

Injection of Ropivacaine in the hepatic hilum for the hepatic hilar nerve block

15 ml sterile normal saline is injected at the hepatic hilum along the anterior surface of the portal vein within 2cm of the bifurcation.

Injection of normal saline in the hepatic hilum for the sham procedure

Louis-Martin Boucher, MD/PhD

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.

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 procedures:

* 80 consecutive subjects meeting the eligibility criteria, scheduled for chemoembolization of the liver for primary or secondary liver malignancies OR radiofrequency ablation of the liver for primary or secondary liver malignancies.
* Consent will be obtained from all patients by an interventional radiologist.
* All procedures will be performed by a qualified interventional radiology medical doctor (IRMD).
* Patients who accept to participate and fit the criteria will be randomized to either receive hepatic plexus block or a placebo control procedure, consisting of injection of normal saline.
* Hepatic hilum plexus nerve block will consist of the ultrasound-guided injection of ropivacaine at the hepatic hilum anterior to the portal vein as close to the bifurcation as possible. In the sham control group, the same location will be targeted, but only normal saline will be injected.
* A member of the radiology technologists will load the syringe with either ropivacaine or normal saline and the IRMD will thus be blinded to the patient's allocated group.
* All patients will be offered IV analgesia using midazolam and fentanyl during the procedure at set regular intervals as per our standard regimen.
* Similar IV analgesics as well as oral analgesics will be provided as per set orders during the recovery period in the post-procedural recovery room (PACU)
* The patient will be discharged home with standard prescriptions for home analgesics which include routine medication and medication to be used for breakthrough pain. While at home they will be entering pain surveys three times per day for three days.
* Data will be gathered, stored, and analyzed. The analysis will be stratified into patients who have received chemoembolization and patients who have received radiofrequency ablation.
* Follow-up of the patient will occur as per routine 4-6 weeks post chemoembolization/radiofrequency ablation to assess the clinical success of the therapeutic procedure (ablation and TACE) and patient satisfaction with pain control.

Subject data collection on the day of the procedure will include demographics, relevant medical history, vital signs before and during the procedure, use of IV analgesics, use of oral analgesics, use of nerve block or sham procedure and visual analogue pain scales at set intervals during hospital stay. Subject data collection while at home will include visual analogue pain scale and self-recording of medication intake.

Prospective Randomized Double-Blinded Trial

A technologist will either load up a syringe with ropivacaine or with saline. He will be the only one knowing what was put in the syringe. The operator will inject the content of the syringe at the location of the hepatic hilar nerve block, not knowing what is being injected.

Hepatic Hilar Nerve Block Versus Sham in Pain Control During Liver Ablation and TACE Procedures

Prospective Randomized Double-Blind Study of Pain Control With Hepatic Hilum Nerve Block Versus Sham Procedure For Hepatic Chemoembolization or Radiofrequency Ablation

No plan to share individual participant data

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.

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

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.

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

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.

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

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.

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

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

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

Incidence of complications (graded based on society of interventional radiology complication grading system) will be calculated for the various grades

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Hepatic Hilar Nerve Block Versus Sham in Pain Control During Liver Ablation and TACE Procedures	NCT04769713	Pain Control Liver Cancer	Hepatic Hilar N... Injection of Ro... Injection of no...	18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre
Hepatic Hilar Nerve Block Versus Sham in Pain Control During Liver Ablation and TACE Procedures	NCT04769713	Pain Control Liver Cancer	Hepatic Hilar N... Injection of Ro... Injection of no...	18 Years -	McGill University Health Centre/Research Institute of the McGill University Health Centre

Spots Global Cancer Trial Database for injection of normal saline in the hepatic hilum for the sham procedure