Blood Loss, SurgicalNCT05035303
Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy (PCNL)?
A study testing Nor-Epinephrine injection versus saline during PCNL in people with Blood Loss, Surgical, run by Benha University at 2 sites in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Nor-Epinephrine injection versus saline during PCNL
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Mar 2020to 1 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- renal stones>2 cm
Who cannot join
- coagulopathy, congenital anomalies, active Urinary tract infections
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Banha University Hospitals
Banhā, Kalubiaya, 13518
Banha university hospital
Banhā, Qalyubia Governorate, 13511
About this study
Official title: 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.
Read the 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.
- Conditions
- Blood Loss, Surgical
- Being tested
- Nor-Epinephrine injection versus saline during PCNL
- Medical subject headings
- Blood Loss, Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nor-Epinephrine injection versus saline during PCNLProcedure or surgery
The PCNL tract is infiltrated by Nor-Epinephrine or Normal Saline before its dilatation.
| Study group | Role | What they receive |
|---|---|---|
| Nor-Epinephrine (NE)-Group | Active comparator | The PCNL tract is infiltrated by Nor-Epinephrine before its dilatation. Receives: Procedure: Nor-Epinephrine injection versus saline during PCNL |
| S-Group | Placebo comparator | The PCNL tract is infiltrated by Normal Saline before its dilatation. Receives: Procedure: Nor-Epinephrine injection versus saline during PCNL |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin drop
the lower drop is better
Measured: 72 hours post intervention
blood loss
the lower loss is better
Measured: immediately after surgery
Secondary outcomes (2)
stone free rate
the higher is better
Measured: within 3 months post-operative
adverse events
the lower is better
Measured: within 30 days post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start10 Mar 2020
- Primary completion10 Nov 2021
- Study completion1 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Waleed El-Shaer, MD, Benha University
- Investigators
- Waleed El-Shaer, Principal investigator, Faculty of medicine, Banha university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05035303
- Sponsor's protocol ID
- RC-200310
- Status last verified
- Jan 2022
- First submitted
- 30 Aug 2021
- Last updated
- 5 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Trajectory Nor-epinephrine Infiltration Reduce Blood Loss During Percutaneous Nephrolithotomy?: A Double-blind Randomized Placebo Controlled Study.
- ClinicalTrials.gov ID
- NCT05035303
- Acronym / sponsor ID
- RC-200310
- Conditions
- Blood Loss, Surgical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 10 Nov 2021 (actual)
- Study completion
- 1 Jan 2022 (actual)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nor-Epinephrine (NE)-Group | Active comparator | Procedure: Nor-Epinephrine injection versus saline during PCNLThe PCNL tract is infiltrated by Nor-Epinephrine before its dilatation. |
| S-Group | Placebo comparator | Procedure: Nor-Epinephrine injection versus saline during PCNLThe PCNL tract is infiltrated by Normal Saline before its dilatation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- renal stones>2 cm
Key exclusion criteria (1 listed)
- coagulopathy, congenital anomalies, active Urinary tract infections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nor-Epinephrine injection versus saline during PCNLThe PCNL tract is infiltrated by Nor-Epinephrine or Normal Saline before its dilatation. | Procedure or surgery | Nor-Epinephrine (NE)-Group, S-Group |
Primary outcome
hemoglobin drop
Time frame: 72 hours post intervention
the lower drop is better
blood loss
Time frame: immediately after surgery
the lower loss is better
2 secondary outcomes
stone free rate
Time frame: within 3 months post-operative
adverse events
Time frame: within 30 days post-operative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waleed El-Shaer principal investigator
Faculty of medicine, Banha university
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nor-Epinephrine injection versus saline during PCNL in people with Blood Loss, Surgical, run by Benha University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemoglobin drop (time frame: 72 hours post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2022.