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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Louis-Martin Boucher, MD/PhD | Contact | 514-934-1934 | 44454 | lmboucher@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McGill University Health Centre | Recruiting | Montreal | Quebec | H4A 3J1 | Canada |
No plan to share individual participant data
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Prospective Randomized Double-Blinded Trial
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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.
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| 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. |
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| 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. |
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| 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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 | 4-6 weeks |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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