The Efficacy of Peritubal Analgesic Infiltration in Postoperative Pain Following Percutaneous Nephrolithotomy

Study Overview
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Brief Summary
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The investigators aim to investigate the effect of peritubal local anesthetic infiltration on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy.

Detailed Description
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The investigators aim to investigate the effect of peritubal local anesthetic on pain scores and analgesic consumption in patients who underwent percutaneous nephrolithotomy. Patients aged between 18 and 65 years with renal stone >2 cm will be included in this study .The patients will be divided into two groups. In Group A , the drug will be infiltrated to the renal capsule, perinephric fat, muscles, subcutaneous tissue, and skin under fluoroscopy with 0.25 percent bupivacaine. This is a widely-used procedure by surgeons in the world. In Group B, no anesthetic will be infiltrated after the end of the procedure.

Official Title
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The Effect of Peritubal Infiltration With Bupivacaine Around Nephrostomy Tract on Postoperative Pain Control After Percutaneous Nephrolithotomy

Conditions
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Renal Stone

Intervention / Treatment
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* Drug: Marcaine Injectable Product


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-70 years of age body mass index <35, renal stone size >2.0 cm. Exclusion Criteria: patients having supra-costal puncture. excessive intraoperative bleeding. renal stones requiring more than a single puncture. surgical procedure extending more than 3 hours. urinary tract infection. severe cardiopulmonary disease. abnormal renal function tests. allergy to local anesthetics.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: study group :infiltration with 0.25% bupivacaine post-op<br>At the end of the procedure ( surgery), In the patients of the study group, the 23-gauge, 90mm spinal needle will inserted up to the renal capsule under fluoroscopic guidance along the nephrostomy tube at 6 and 12 o'clock positions (cranial and caudal); then 20 ml of 0.25% bupivacaine will infiltrated into the nephrostomy tract, while gradually withdrawing the needle from renal capsule to the skin thereby infiltrating the renal capsule, perinephric fat, muscles, subcutaneous tissue and skin | Drug: Marcaine Injectable Product<br>* Following PCNL under general anesthesia, patients will receive 0.25% Bupivacaine ( Marcaine) local anesthetic infiltration<br>* Other names: Sensorcaine Injectable Product;|
| No Intervention: control group , no anesthesia infiltration post-op<br>control group: no anesthesia infiltration had been given post opertatively | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analogue scale (VAS ) | Visual Analogue Scale (VAS), the patient is asked to describe the level of pain on a visual scale at rest at 1, 4, 8, 12, 24, and 48 hours | 1, 4, 8, 12, 24, and 48 hours | 
| Dynamic Visual Analogue Scale (DVAS) | Dynamic Visual Analogue Scale (DVAS), the patient is asked to describe the level of pain on a visual scale during breathing at 1, 4, 8, 12, 24, and 48 hours | 1 hour, 4 hours, 8 hours, 12 hours, 24 hours, and 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time for the first opioid demand | first post op time for analgesia | 48 hours | 
| the number of opioid demands | total number of opioid given to the patient | 48 hours | 
| total opioid consumption | total amount of opioid consumption | 48 hours |