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Completed

NCT Number: NCT05035303

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

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.

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Key information

Conditions

Blood Loss, Surgical Hemorrhage Intraoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banha University Hospitals, Banhā, Kalubiaya, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • renal stones>2 cm

Exclusion criteria

  • coagulopathy, congenital anomalies, active Urinary tract infections

Treatment and study plan

Nor-Epinephrine injection versus saline during PCNL

Procedure

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

Primary outcomes

  1. hemoglobin drop

    Time frame: 72 hours post intervention

    the lower drop is better

  2. blood loss

    Time frame: immediately after surgery

    the lower loss is better

Secondary outcomes

  1. stone free rate

    Time frame: within 3 months post-operative

    the higher is better

  2. adverse events

    Time frame: within 30 days post-operative

    the lower is better

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 5, 2021
Registry last updated
Jan 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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