Success of Paravertebral Blocks in Analgesia for Interventional Hepatic Procedures

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomised Double Blind Controlled Study of the Effectiveness of Paravertebral Nerve Block in Decreasing Analgesia Requirements and Improving Patient Experience During Interventional Hepatic Procedures.

Conditions
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Liver Neoplasms

Intervention / Treatment
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* Procedure: Paravertebral block
* Procedure: Control sham procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or non-pregnant female subjects, between the ages of 18 and 80 at the time of enrollment. 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 who participated in an active stage of any drug, intervention or treatment trial within 30 days of enrollment. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paravertebral block<br>Paravertebral space will be needled and an anesthetic agent will be injected. | Procedure: Paravertebral block<br>* Injection of local anaesthesia into paravertebral space to provide analgesia<br>|
| Placebo Comparator: Control sham procedure<br>Paravertebral space will be needled, but only normal saline injected. | Procedure: Control sham procedure<br>* Injection of Normal saline into the paravertebral space<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose of intravenous sedation required during and after the procedure |  | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in analogue pain scoring after the procedure |  | 1 hour | 
| Procedure duration |  | 1 hour | 
| Complication rate of liver procedure |  | 24 hours | 
| Complication rate of paravertebral block |  | 1 hour |