Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy (PCNL)?

Study Overview
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Brief Summary
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during PCNL; A few milliliters of nor-epinephrine is injected into the intended tract after puncture of pelvicalyceal system and before its dilatation compared to injection of saline (placebo). hemoglobin change & blood loss is estimated and will compared.

Detailed Description
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All patients of are positioned in lithotomy position and 6 F open tip ureteral catheter is fixed by cystoscope. Then, A pelvicalyceal system is punctured under ultrasound and/or fluoroscopic guidance, then a 18 Gauge (G) puncture needle is introduced toward the desired calyx and a 0.038 inch guide wire is inserted. then 20 G Chiba needle is introduced alongside the puncture needle for infiltration of the whole tract by either a few milliliters of nor-epinephrine or saline. then, the tract is dilated over the guide wire, lastly an Amplatz sheath was inserted. nephroscope is used for stones disintegration by pneumatic or laser lithotripter . Fragments are washed out or removed by forceps.

Official Title
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Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy?: A Double-blind Randomized Placebo Controlled Study.

Conditions
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Blood Loss, Surgical

Intervention / Treatment
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* Procedure: Nor-Epinephrine injection versus saline during PCNL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: renal stones>2 cm Exclusion Criteria: coagulopathy, congenital anomalies, active Urinary tract infections

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nor-Epinephrine (NE)-Group<br>The PCNL tract is infiltrated by Nor-Epinephrine before its dilatation. | Procedure: Nor-Epinephrine injection versus saline during PCNL<br>* The PCNL tract is infiltrated by Nor-Epinephrine or Normal Saline before its dilatation.<br>|
| Placebo Comparator: S-Group<br>The PCNL tract is infiltrated by Normal Saline before its dilatation. | Procedure: Nor-Epinephrine injection versus saline during PCNL<br>* The PCNL tract is infiltrated by Nor-Epinephrine or Normal Saline before its dilatation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemoglobin drop | the lower drop is better | 72 hours post intervention | 
| blood loss | the lower loss is better | immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stone free rate | the higher is better | within 3 months post-operative | 
| adverse events | the lower is better | within 30 days post-operative |