Pain ControlPhase 4NCT04769713
Hepatic Hilar Nerve Block Versus Sham in Pain Control During Liver Ablation and TACE Procedures
A Phase 4 study testing Hepatic Hilar Nerve Block Needle placement and Injection of Ropivacaine in the hepatic hilum for the hepatic hilar nerve block in people with Pain Control and Liver Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Control, Liver Cancer
- What is being tested?
- Hepatic Hilar Nerve Block Needle placement and Injection of Ropivacaine in the hepatic hilum for the hepatic hilar nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 23 Nov 2021to 30 Sep 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
McGill University Health Centre
Montreal, Quebec, H4A 3J1
Louis-Martin Boucher, MD/PhD, 514 934-1934 ext. 44454, lmboucher@yahoo.com
About this study
Official title: Prospective Randomized Double-Blind Study of Pain Control With Hepatic Hilum Nerve Block Versus Sham Procedure For Hepatic Chemoembolization or Radiofrequency Ablation
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.
Read the detailed description
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.
- Conditions
- Pain Control, Liver Cancer
- Being tested
- 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
- Medical subject headings
- Agnosia, Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatic Hilar Nerve Block Needle placementProcedure or surgery
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 blockDrug
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 procedureDrug
15 ml sterile normal saline is injected at the hepatic hilum along the anterior surface of the portal vein within 2cm of the bifurcation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: Hepatic Hilar Nerve Block Needle placement; Drug: Injection of normal saline in the hepatic hilum for the sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 1 day
Secondary outcomes (9)
Changes in pain after a hepatic hilar nerve block in the early days following 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 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.
Measured: 3 days
Changes in narcotic use after a hepatic hilar nerve block in the early days after liver ablation
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
Measured: 3 days
Changes in pain after a hepatic hilar nerve block in the early days following 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 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.
Measured: 3 days
Changes in narcotic use after a hepatic hilar nerve block in the early days after liver chemoembolization
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
Measured: 3 days
Changes in anti-nausea medication use after a hepatic hilar nerve block during and immediately after liver ablation
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
Measured: 1 day
Changes in anti-nausea medication use after a hepatic hilar nerve block during and immediately after liver chemoembolization
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
Measured: 1 day
Incidence of complications secondary to performing the hepatic hilar nerve block
Incidence of complications (graded based on society of interventional radiology complication grading system) will be calculated for the various grades
Measured: 4-6 weeks
Differences in disease response post liver tumoral ablation between patients with hepatic hilar nerve block and those with sham procedure
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
Measured: 4-6 weeks
Differences in disease response post liver tumoral chemoembolization between patients with hepatic hilar nerve block and those with 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
Measured: 4-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start23 Nov 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ControlStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Double-Blinded Trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis-martin Boucher, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04769713
- Sponsor's protocol ID
- 2021-7139
- Status last verified
- May 2023
- First submitted
- 8 Dec 2020
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Double-Blind Study of Pain Control With Hepatic Hilum Nerve Block Versus Sham Procedure For Hepatic Chemoembolization or Radiofrequency Ablation
- ClinicalTrials.gov ID
- NCT04769713
- Acronym / sponsor ID
- 2021-7139
- Conditions
- Pain Control, Liver Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 24 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Prospective Randomized Double-Blinded Trial
| Arm | Type | Receives |
|---|---|---|
| Hepatic hilar nerve block in ablation patients | Experimental | Procedure: Hepatic Hilar Nerve Block Needle placement, Drug: Injection of Ropivacaine in the hepatic hilum for the hepatic hilar nerve block15ml 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 procedure in ablation patients | Placebo comparator | Procedure: Hepatic Hilar Nerve Block Needle placement, Drug: Injection of normal saline in the hepatic hilum for the sham procedure15ml 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. |
| Hepatic hilar nerve block in chemoembolization patients | Experimental | Procedure: Hepatic Hilar Nerve Block Needle placement, Drug: Injection of Ropivacaine in the hepatic hilum for the hepatic hilar nerve block15ml 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 procedure in chemoembolization patients | Placebo comparator | Procedure: Hepatic Hilar Nerve Block Needle placement, Drug: Injection of normal saline in the hepatic hilum for the sham procedure15ml 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatic Hilar Nerve Block Needle placementPlacement 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. | Procedure or surgery | 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 blockInjection of 15 ml 0.5% Ropivacaine at the hepatic hilum along the anterior surface of the portal vein within 2cm of the bifurcation. | Drug | 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 procedure15 ml sterile normal saline is injected at the hepatic hilum along the anterior surface of the portal vein within 2cm of the bifurcation. | Drug | Placebo procedure in ablation patients, Placebo procedure in chemoembolization patients |
Primary outcome
Changes in pain after a hepatic hilar nerve block during and immediately after liver ablation
Time frame: 1 day
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.
Changes in narcotic use after a hepatic hilar nerve block during and immediately after liver ablation
Time frame: 1 day
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
Changes in pain after a hepatic hilar nerve block during and immediately after liver chemoembolization
Time frame: 1 day
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.
Changes in narcotic use after a hepatic hilar nerve block during and immediately after liver chemoembolization
Time frame: 1 day
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
9 secondary outcomes
Changes in pain after a hepatic hilar nerve block in the early days following liver ablation
Time frame: 3 days
Changes in narcotic use after a hepatic hilar nerve block in the early days after liver ablation
Time frame: 3 days
Changes in pain after a hepatic hilar nerve block in the early days following liver chemoembolization
Time frame: 3 days
Changes in narcotic use after a hepatic hilar nerve block in the early days after liver chemoembolization
Time frame: 3 days
Changes in anti-nausea medication use after a hepatic hilar nerve block during and immediately after liver ablation
Time frame: 1 day
Changes in anti-nausea medication use after a hepatic hilar nerve block during and immediately after liver chemoembolization
Time frame: 1 day
Incidence of complications secondary to performing the hepatic hilar nerve block
Time frame: 4-6 weeks
Differences in disease response post liver tumoral ablation between patients with hepatic hilar nerve block and those with sham procedure
Time frame: 4-6 weeks
Differences in disease response post liver tumoral chemoembolization between patients with hepatic hilar nerve block and those with sham procedure
Time frame: 4-6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No. No plan to share individual participant data
Related trials for Pain Control
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
Recruiting
Effects of a Prebiotic-Probiotic Combination on Constipation Symptoms and Quality of Life
Constipation, Abdominal Pain
Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hepatic Hilar Nerve Block Needle placement and Injection of Ropivacaine in the hepatic hilum for the hepatic hilar nerve block in people with Pain Control and Liver Cancer, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louis-Martin Boucher, MD/PhD (514-934-1934 ext. 44454, lmboucher@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pain after a hepatic hilar nerve block during and immediately after liver ablation (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.