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

Blood Loss, Surgical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05035303
• Other study ID #: RC-200310
• Status: Completed
• Phase: N/A
• Start date: March 10, 2020
• Est. completion date: January 1, 2022

Study information

• Verified date: January 2022
• Source: Benha University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 1, 2022
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• renal stones>2 cm

Exclusion Criteria:

• coagulopathy, congenital anomalies, active Urinary tract infections

Related Conditions & MeSH terms

• Blood Loss, Surgical
• Hemorrhage

Intervention

Procedure:
• Nor-Epinephrine injection versus saline during PCNL
The PCNL tract is infiltrated by Nor-Epinephrine or Normal Saline before its dilatation.

Locations

Country	Name	City	State
Egypt	Banha university hospital	Banha	Qalubia
Egypt	Banha University Hospitals	Banha	Kalubiaya

Sponsors (1)

Lead Sponsor	Collaborator
Benha University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin drop	the lower drop is better	72 hours post intervention
Primary	blood loss	the lower loss is better	immediately after surgery
Secondary	stone free rate	the higher is better	within 3 months post-operative
Secondary	adverse events	the lower is better	within 30 days post-operative