Back to resultsCan Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy (PCNL)?
Primary Purpose
Blood Loss, Surgical
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nor-Epinephrine injection versus saline during PCNL
Sponsored by
About this trial
This is an interventional prevention trial for Blood Loss, Surgical
Eligibility Criteria
Inclusion Criteria:
- renal stones>2 cm
Exclusion Criteria:
- coagulopathy, congenital anomalies, active Urinary tract infections
Sites / Locations
- Banha University Hospitals
- Banha university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Nor-Epinephrine (NE)-Group
S-Group
Arm Description
The PCNL tract is infiltrated by Nor-Epinephrine before its dilatation.
The PCNL tract is infiltrated by Normal Saline before its dilatation.
Outcomes
Primary Outcome Measures
hemoglobin drop
the lower drop is better
blood loss
the lower loss is better
Secondary Outcome Measures
stone free rate
the higher is better
adverse events
the lower is better
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05035303
Brief Title
Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy (PCNL)?
Official Title
Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy?: A Double-blind Randomized Placebo Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 10, 2020 (Actual)
Primary Completion Date
November 10, 2021 (Actual)
Study Completion Date
January 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Surgical
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
double- blinded
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nor-Epinephrine (NE)-Group
Arm Type
Active Comparator
Arm Description
The PCNL tract is infiltrated by Nor-Epinephrine before its dilatation.
Arm Title
S-Group
Arm Type
Placebo Comparator
Arm Description
The PCNL tract is infiltrated by Normal Saline before its dilatation.
Intervention Type
Procedure
Intervention Name(s)
Nor-Epinephrine injection versus saline during PCNL
Intervention Description
The PCNL tract is infiltrated by Nor-Epinephrine or Normal Saline before its dilatation.
Primary Outcome Measure Information:
Title
hemoglobin drop
Description
the lower drop is better
Time Frame
72 hours post intervention
Title
blood loss
Description
the lower loss is better
Time Frame
immediately after surgery
Secondary Outcome Measure Information:
Title
stone free rate
Description
the higher is better
Time Frame
within 3 months post-operative
Title
adverse events
Description
the lower is better
Time Frame
within 30 days post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
renal stones>2 cm
Exclusion Criteria:
coagulopathy, congenital anomalies, active Urinary tract infections
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waleed El-Shaer
Organizational Affiliation
Faculty of medicine, Banha university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Banha University Hospitals
City
Banha
State/Province
Kalubiaya
ZIP/Postal Code
13518
Country
Egypt
Facility Name
Banha university hospital
City
Banhā
State/Province
Qalubia
ZIP/Postal Code
13511
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy (PCNL)?
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