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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05035303

Enrollment

140

Registered

2021-09-05

Start date

2020-03-10

Completion date

2022-01-01

Last updated

2022-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Surgical

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.

Interventions

PROCEDURENor-Epinephrine injection versus saline during PCNL

The PCNL tract is infiltrated by Nor-Epinephrine or Normal Saline before its dilatation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

double- blinded

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* renal stones\>2 cm

Exclusion criteria

* coagulopathy, congenital anomalies, active Urinary tract infections

Design outcomes

Primary

Measure	Time frame	Description
hemoglobin drop	72 hours post intervention	the lower drop is better
blood loss	immediately after surgery	the lower loss is better

Secondary

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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026