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

NCT04769713 | Unknown Phase 4 DMC

• 1 other identifier: 2021-7139
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Pain Control; Liver Cancer

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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 Outcomes (9)

• Changes in pain after a hepatic hilar nerve block in the early days following liver ablation

  3 days

• Changes in narcotic use after a hepatic hilar nerve block in the early days after liver ablation

  3 days

• Changes in pain after a hepatic hilar nerve block in the early days following liver chemoembolization

  3 days

• Changes in narcotic use after a hepatic hilar nerve block in the early days after liver chemoembolization

  3 days

• Changes in anti-nausea medication use after a hepatic hilar nerve block during and immediately after liver ablation

  1 day

Study Arms (4)

Hepatic hilar nerve block in ablation patients

EXPERIMENTAL

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.

Procedure: Hepatic Hilar Nerve Block Needle placement; Drug: Injection of Ropivacaine in the hepatic hilum for the hepatic hilar nerve block

Placebo procedure in ablation patients

PLACEBO COMPARATOR

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.

Procedure: Hepatic Hilar Nerve Block Needle placement; Drug: Injection of normal saline in the hepatic hilum for the sham procedure

Hepatic hilar nerve block in chemoembolization patients

EXPERIMENTAL

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.

Procedure: Hepatic Hilar Nerve Block Needle placement; Drug: Injection of Ropivacaine in the hepatic hilum for the hepatic hilar nerve block

Placebo procedure in chemoembolization patients

PLACEBO COMPARATOR

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.

Procedure: Hepatic Hilar Nerve Block Needle placement; Drug: Injection of normal saline in the hepatic hilum for the sham procedure

Interventions

Hepatic Hilar Nerve Block Needle placement 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 in ablation patients; Hepatic hilar nerve block in chemoembolization patients; Placebo procedure in ablation patients; Placebo procedure in chemoembolization patients

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

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

Hepatic hilar nerve block in ablation patients; Hepatic hilar nerve block in chemoembolization patients

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

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

Placebo procedure in ablation patients; Placebo procedure in chemoembolization patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

MeSH Terms

Conditions

Agnosia; Liver Neoplasms

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Central Study Contacts

Louis-Martin Boucher, MD/PhD

CONTACT

514-934-1934; lmboucher@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Diagnostic Radiology - Interventional Radiology Division

Model Details: Prospective Randomized Double-Blinded Trial

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: February 24, 2021
• Study Start: November 23, 2021
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)