Recruiting

Hepatic Hilar Nerve Block vs. Sham

Sponsor:

McGill University Health Centre/Research Institute of the McGill University Health Centre

Code:

NCT04769713

Conditions

Pain Control

Liver Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Hepatic Hilar Nerve Block Needle placement

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

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

Study Details

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

Study ID

NCT04769713

Start date

Nov 23, 2021

Status verified date

May, 2023

Completion date

Sep 30, 2023

Anticipated

Primary completion date

Jun 30, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Hepatic hilar nerve block in ablation patients

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.

placebo comparator: Placebo procedure in ablation patients

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.

experimental: Hepatic hilar nerve block in chemoembolization patients

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.

placebo comparator: Placebo procedure in chemoembolization patients

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.

Interventions

Hepatic Hilar Nerve Block Needle placement

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.

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

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 normal saline in the hepatic hilum for the sham procedure

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

Primary outcome measure

  • Changes in pain after a hepatic hilar nerve block during and immediately after liver ablation [ Time Frame: 1 day ]
  • Changes in narcotic use after a hepatic hilar nerve block during and immediately after liver ablation [ Time Frame: 1 day ]
  • Changes in pain after a hepatic hilar nerve block during and immediately after liver chemoembolization [ Time Frame: 1 day ]
  • Changes in narcotic use after a hepatic hilar nerve block during and immediately after liver chemoembolization [ Time Frame: 1 day ]

Central Contacts and Locations

Central contacts

Louis-Martin Boucher, MD/PhD

514-934-1934lmboucher@yahoo.com

Locations

McGill University Health Centre

Recruiting

Montréal, Quebec, Canada, H4A 3J1

Contacts

Louis-Martin Boucher, MD/PhD

514 934-1934lmboucher@yahoo.com

More Information

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Last update posted

Jun 2, 2023

Last verified

May, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2023-06-02.