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

Not Applicable

Completed

• Conditions: Blood Loss, Surgical
• Interventions: Procedure: Nor-Epinephrine injection versus saline during PCNL

• Registration Number: NCT05035303
• Lead Sponsor: Benha University

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-03-10
• Study First Submitted: 2021-08-30
• Study First Submitted QC: 2021-08-30
• Study First Posted: 2021-09-05
• Primary Completion: 2021-11-10
• Status Verified: 2022-01
• Study Completion: 2022-01-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• renal stones>2 cm

Exclusion Criteria

• coagulopathy, congenital anomalies, active Urinary tract infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
S-Group	Nor-Epinephrine injection versus saline during PCNL	The PCNL tract is infiltrated by Normal Saline before its dilatation.
Nor-Epinephrine (NE)-Group	Nor-Epinephrine injection versus saline during PCNL	The PCNL tract is infiltrated by Nor-Epinephrine before its dilatation.

Primary Outcome Measures

Name	Time	Method
blood loss	immediately after surgery	the lower loss is better
hemoglobin drop	72 hours post intervention	the lower drop is better

Secondary Outcome Measures

Name	Time	Method
adverse events	within 30 days post-operative	the lower is better
stone free rate	within 3 months post-operative	the higher is better

Trial Locations

Locations (2)

Banha University Hospitals; 🇪🇬 Banha, Kalubiaya, Egypt

Banha university hospital; 🇪🇬 Banhā, Qalubia, Egypt