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Institutional Ethics Board concern regarding sham procedure, requiring modifications that are not feasible within the man-power limitations of our institution.
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This study is aimed at assessing whether performing a paravertebral block (a type of regional pain relief) can reduce the pain and anxiety patients experience during radiological procedures on the liver.
Percutaneous procedures of the liver can be very painful and range from bliliary drain insertions to tumor ablation procedures. The study will randomize patients in two groups, one receiving a paravertebral nerve block prior to the procedure and one receiving a sham procedure in which saline will be injected in the paravertebral space. Pain scores and use of IV sedation will be monitored post procedure and both groups will be compared to assess whether paravetebral nerve blocks are effective at reducing pain in patients receiving such procedures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paravertebral block | Experimental | Paravertebral space will be needled and an anesthetic agent will be injected. |
|
| Control sham procedure | Placebo Comparator | Paravertebral space will be needled, but only normal saline injected. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paravertebral block | Procedure | Injection of local anaesthesia into paravertebral space to provide analgesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose of intravenous sedation required during and after the procedure | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in analogue pain scoring after the procedure | 1 hour | |
| Procedure duration | 1 hour | |
| Complication rate of liver procedure |
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Inclusion Criteria:
Subjects referred for liver/biliary interventions to the angiography department.
Written informed consent to participate in the study. Ability to comply with the requirements of the study procedures
Exclusion Criteria:
Subjects with preexisting conditions, which, in the opinion of the investigator, interfere with the conduct of the study. Patients will only be excluded on this basis following discussion with another interventional radiologist.
Subjects who are uncooperative or cannot follow instructions. Mental state that may preclude completion of the study procedure or ability to obtain informed consent.
Pregnant or nursing female subjects. Patient who are to undergo liver biopsy or routine biliary tube exchange. Patients with neurological/spinal conditions, or a BMI over 40, that would prevent safe/effective or well-targeted paravertebral blockade.
Patient unable to tolerate the paravertebral block procedure, for example due to inability to lie prone
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| Name | Affiliation | Role |
|---|---|---|
| Richard Lindsay, MB Bch | McGill University Health Centre/Research Institute of the McGill University Health Centre | Principal Investigator |
| Louis Boucher, MD | McGill University Health Centre/Research Institute of the McGill University Health Centre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Victoria Hospital | Montreal | Quebec | H3A 1A1 | Canada | ||
| Montreal General Hospital |
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| ID | Term |
|---|---|
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
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| Control sham procedure | Procedure | Injection of Normal saline into the paravertebral space |
|
| 24 hours |
| Complication rate of paravertebral block | 1 hour |
| Montreal |
| Quebec |
| H3G 1A4 |
| Canada |
| D008107 |
| Liver Diseases |