The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration

Study Overview
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Brief Summary
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Percutaneous nephrolithotomy (PCNL) is a safe and effective procedure that is considered the standard treatment for large and complex renal stones. Although it has lower complication and morbidity rates than open surgery, the pain and discomfort related to a nephrostomy tube can cause distress for patients. Managing this pain with opioids can lead to sedation, nausea, vomiting, and constipation, which defeat the purpose of this minimally invasive procedure. Skin infiltration with bupivacaine around the nephrostomy tube is not effective. Infiltration of renal capsule has shown to facilitate painless insertion of nephrostomy tube, suggesting the role of renal capsule in pain management. Peritubal infiltration of bupivacaine from renal capsule to the skin along the nephrostomy tract may alleviate postoperative pain. A unilateral Low thoracic paravertebral (PVB) block offers the option of providing extendable perioperative pain relief without the above side effects or the physiologic derangement associated with local anesthetics in the central neuraxial space. The aim of this study is to determine whether ultrasound guided low thoracic paravertebral block effective post-operative analgesia as compared to peritubal infiltration analgesia in patients undergoing percutaneous nephrolithotomy. Main outcome measures: The primary endpoint is postoperative opioid consumption. Secondary endpoints are visual analogue pain scores, opioid related side effects.

Official Title
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The Comparison of Low Thoracic Paravertebral Block Versus Peritubal Infiltration in Patients Undergoing Percutaneous Nephrolithotomy

Conditions
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Percutaneous Nephrolithotomy

Intervention / Treatment
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* Drug: Bupivacaine
* Device: Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist's physiologic state I-III patients undergoing percutaneous nephrolithotomy Exclusion Criteria: chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: Low thoracic paravertebral block<br>T8-T9 Ultrasound guided paravertebral block with 20 ml %0,25 bupivacaine | Drug: Bupivacaine<br>* 20 ml %0,25 bupivacaine<br>Device: Ultrasound<br> <br> |
| Active Comparator: Peritubal infiltration<br>Peritubal infiltration with 20 ml %0,25 bupivacaine | Drug: Bupivacaine<br>* 20 ml %0,25 bupivacaine<br>|
| No Intervention: Control Group<br>No drug | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption |  | First 24 hours total opioid consumption | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at first hour postoperatively. | postoperative first hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at second hour postoperatively. | postoperative second hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 4th hour postoperatively | postoperative 4th hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain) at 8th hour postoperatively | postoperative 8th hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS)score of 0-10 (0= no pain and 10= worst imaginable pain) at 12th hour postoperatively. | postoperative 12th hour | 
| Visual analog pain score | Post operative pain will be evaluated with a Visual Analogue Scale (VAS)score of 0-10 (0= no pain and 10= worst imaginable pain) at 24th hour postoperatively | postoperative 24th hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Analgesia, Peritubal infiltration, Ultrasound guided low thoracic paravertebral block, Percutaneous Nephrolithotomy pain