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.

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.

Study Overview

• Status: Completed
• Conditions: Blood Loss, Surgical
• Intervention / Treatment: Procedure: Nor-Epinephrine injection versus saline during PCNL

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kalubiaya
    • Banha, Kalubiaya, Egypt, 13518
      • Banha University Hospitals
  • Qalubia
    • Banhā, Qalubia, Egypt, 13511
      • Banha University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• renal stones>2 cm

Exclusion Criteria:

• coagulopathy, congenital anomalies, active Urinary tract infections

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Benha University
• Investigators: Principal Investigator: Waleed El-Shaer, Faculty of medicine, Banha university

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2020
• Primary Completion (Actual): November 10, 2021
• Study Completion (Actual): January 1, 2022

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: August 30, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): January 5, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Intraoperative Complications; Hemorrhage; Blood Loss, Surgical; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic alpha-Agonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-Agonists; Sympathomimetics; Vasoconstrictor Agents; Mydriatics; Norepinephrine; Epinephrine
• Other Study ID Numbers: RC-200310

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No