Paravertebral Block for Percutaneous Nephrolithotomy

Study Overview
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Brief Summary
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This study will compare post-operative pain levels in patients who receive paravertebral block prior to Percutaneous Nephrolithotomy (PCNL) surgery versus those who do not receive the block. We hypothesize that patients who receive the block will have lower post-operative pain scores and require less narcotics.

Detailed Description
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The strategies used to manage nephrolithiasis including medical expulsive therapy, extracorporeal shock wave (ESWL), ureteroscopy, open surgery and percutaneous nephrolithotomy (PCNL). PCNL in an inpatient procedure performed in two steps. Step 1, is the placement of a drainage line (nephrostomy tube) from the back into the collecting system of the kidney. This step is typically performed by interventional radiologists under conscious sedation. Step 2 is performed by urologists and involves dilating the tract of the nephrostomy tube, placement of an access sheath and actual removal of the stone using endoscopic equipment. The minimally invasive approach of PCNL is well accepted to be as effective as open procedures for stone removal with less morbidity. Post-operative pain management remains challenging and can lead to extended hospital stays. This randomized, double-blinded trial designed to assess the effects of paravertebral block on intra-operative and post-operative pain control.

Official Title
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Paravertebral Block for Percutaneous Nephrolithotomy (PRONE)

Conditions
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Post Operative Pain

Intervention / Treatment
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* Drug: Group A-Paravertebral block
* Other: Group B- No block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consent to undergo percutaneous nephrolithotomy Between the ages of 18 and 75 Able to consent, fill out study documents, and complete all study procedures and follow-up visits Exclusion Criteria: Will have bilateral percutaneous nephrolithotomy Have an infection at the site of the proposed block Have anatomy that prevents ability to perform block Have a coagulopathy which may increase their chances of bleeding from the block Have a known allergy to local anesthetics Are unable to fill out the VAS scale due to physical or mental conditions Are unable to use a patient controlled analgesia (PCA) device due to physical or mental conditions Are pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group B- No Block<br>Participants randodmized to this arm will have a local anesthetic injection and pressure applied to the paravertebral space. A paravertebral injection will not be conducted. | Other: Group B- No block<br>* direct pressure for 5 minutes will be held at the site of the where the local anesthetic was applied to mimic the application of the block.<br>* Other names: Placebo Group;|
| Active Comparator: Group A- Paravertebral block<br>Participants randodmized to this arm will have a local anesthetic (Bupivicaine 0.5% without epinephrine) injection and will be given a paravetebral block into the T10 paravertebral space.. | Drug: Group A-Paravertebral block<br>* Bupivicaine 0.5% without epinephrine (100mg)20cc will be injected into the T10 paravertebral space. Active Group<br>* Other names: Group A-Paravertebral block Active Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Score | post-operative pain will be measured by the Visual Analog Scale (VAS. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opiod Use | All patients will receive the same post-operative pain control, which does not deviate from our standard protocol for patients receiving PCNL. All patients will be immediately given a PCA in recovery. Patients allergic to morphine/dilaudid will be given a narcoticopioid substitute (that will be converted to morphine equivalents for the purpose of the study). Nurses will be allowed to administer IV boluses of morphine PRN for inadequate pain control. If four boluses did not yield adequate analgesia, fentayl 50mcg will be used until adequate pain control is achieved. | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percutaneous nephrolithotomy, Paravertebral block, bupivacaine