NephrolithiasisNCT02986997
Over 2000 Epidural Anesthesias for Percutaneous Nephrolithotomy - a Retrospective Analysis
An observational study of Nephrolithiasis and Anesthesia, Local, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Percutaneous nephrolithotomy (PNL) is a renal lithiasis treatment. It is usually two staged: it begins in the lithotomy position for ureteral catheter placement and retrograde pyelography and, subsequently, an optimal renal access is obtained in the prone position. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nephrolithiasis, Anesthesia, Local
- How many people
- 2,000 participants
- Where
- 1 sitePoland
- Study dates
- Dec 2016to Sep 2017
- Phase
- Observational
- 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
Study population: Patients that have PNL procedure performed in the Urology Department (Medical University of Warsaw) 2005-2015
Who may be able to join
- PNL procedure
Who cannot join
- no PNL procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Over 2000 Procedures of Epidural Anesthesia for Percutaneous Nephrolithotomy - a Retrospective Analysis
Percutaneous nephrolithotomy (PNL) is a renal lithiasis treatment. It is usually two staged: it begins in the lithotomy position for ureteral catheter placement and retrograde pyelography and, subsequently, an optimal renal access is obtained in the prone position. In most of the centers, the PNL is done under general anesthesia (GA) that is associated with a risk of complications due to putting an intubated, muscle-relaxed, unconscious patient in a prone position. In our Department the procedure is usually performed under epidural anesthesia. The aim of this study was to evaluate the epidural anesthesia performed for PNL over the last decade in the Medical University of Warsaw Urology Department
Read the detailed description
Percutaneous nephrolithotomy is a renal lithiasis endoscopic treatment. It is usually two staged: it begins in the lithotomy position for ureteral catheter placement and retrograde pyelography and, subsequently, an optimal renal access is obtained in the prone position. The PNL is usually two staged. It begins in the lithotomy position for cystoscopic placement of ureteral catheter and retrograde pyelography and, subsequently, a patient is placed mainly in the prone position for percutaneous access and stone removal. This position offers more options for puncture.
In most of the centers, the PNL is done under GA, that is associated with a risk of complications due to putting an intubated, muscle-relaxed, unconscious patient in a prone position. Other complications, including blood transfusion, nausea and vomiting or fever, are more often observed after the general then after the regional anesthesia; the cost of general anesthesia is also higher. The regional anesthesia that can be performed independently for the PNL includes spinal, epidural or combined spinal-epidural blocks. A segmental epidural block is better than spinal anesthesia in terms of hemodynamic stability, postoperative analgesia, patient's satisfaction and reduced incidence of postoperative nausea and vomiting. For epidural anesthesia it takes longer to act than for spinal one but it allows avoiding the motor block so the patient can change the position from lithotomy into prone himself with a little assistance. The position of a patient should not be changed rapidly right after the spinal anesthesia has been performed, due to the risk of too high anesthesia level and hemodynamic complications.
The aim of the study was to evaluate the epidural anesthesia performed for PNL over the last decade in the Medical University of Warsaw Urology Department.
- Conditions
- Nephrolithiasis, Anesthesia, Local
- Keywords
- epidural anesthesia, prone position, percutaneous nephrolithotomy
- Medical subject headings
- Nephrolithiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
effectiveness of epidural anesthesia for PNL evaluated by a number of participants having this procedure completed
The investigator evaluates whether the procedure could be completely performed under epidural anesthesia
Measured: 5 months
Secondary outcomes (1)
Epidural anesthesia complication rate evaluated by a number of vessel or spinal puncture
The investigator counts all the vessel and spinal punctures done with the Tuohy needle
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionAug 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NephrolithiasisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karolina Dobrońska, Medical University of Warsaw
- Investigators
- Karolina Dobronska, MD, Principal investigator, I Department of Anaesthesiology and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02986997
- Sponsor's protocol ID
- U/1/2016
- Status last verified
- Apr 2017
- First submitted
- 6 Dec 2016
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Over 2000 Procedures of Epidural Anesthesia for Percutaneous Nephrolithotomy - a Retrospective Analysis
- ClinicalTrials.gov ID
- NCT02986997
- Acronym / sponsor ID
- U/1/2016
- Conditions
- Nephrolithiasis, Anesthesia, Local
- Keywords
- epidural anesthesia, prone position, percutaneous nephrolithotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 8 Dec 2016 (estimated)
- 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.
Percutaneous nephrolithotomy (PNL) is a renal lithiasis treatment. It is usually two staged: it begins in the lithotomy position for ureteral catheter placement and retrograde pyelography and, subsequently, an optimal renal access is obtained in the prone position. In most of the centers, the PNL is done under general anesthesia (GA) that is associated with a risk of complications due to putting an intubated, muscle-relaxed, unconscious patient in a prone position. In our Department the procedure is usually performed under epidural anesthesia. The aim of this study was to evaluate the epidural anesthesia performed for PNL over the last decade in the Medical University of Warsaw Urology Department
Detailed description
Percutaneous nephrolithotomy is a renal lithiasis endoscopic treatment. It is usually two staged: it begins in the lithotomy position for ureteral catheter placement and retrograde pyelography and, subsequently, an optimal renal access is obtained in the prone position. The PNL is usually two staged. It begins in the lithotomy position for cystoscopic placement of ureteral catheter and retrograde pyelography and, subsequently, a patient is placed mainly in the prone position for percutaneous access and stone removal. This position offers more options for puncture.
In most of the centers, the PNL is done under GA, that is associated with a risk of complications due to putting an intubated, muscle-relaxed, unconscious patient in a prone position. Other complications, including blood transfusion, nausea and vomiting or fever, are more often observed after the general then after the regional anesthesia; the cost of general anesthesia is also higher. The regional anesthesia that can be performed independently for the PNL includes spinal, epidural or combined spinal-epidural blocks. A segmental epidural block is better than spinal anesthesia in terms of hemodynamic stability, postoperative analgesia, patient's satisfaction and reduced incidence of postoperative nausea and vomiting. For epidural anesthesia it takes longer to act than for spinal one but it allows avoiding the motor block so the patient can change the position from lithotomy into prone himself with a little assistance. The position of a patient should not be changed rapidly right after the spinal anesthesia has been performed, due to the risk of too high anesthesia level and hemodynamic complications.
The aim of the study was to evaluate the epidural anesthesia performed for PNL over the last decade in the Medical University of Warsaw Urology Department.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have PNL procedure performed in the Urology Department (Medical University of Warsaw) 2005-2015
Key inclusion criteria (1 listed)
- PNL procedure
Key exclusion criteria (1 listed)
- no PNL procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
effectiveness of epidural anesthesia for PNL evaluated by a number of participants having this procedure completed
Time frame: 5 months
The investigator evaluates whether the procedure could be completely performed under epidural anesthesia
1 secondary outcome
Epidural anesthesia complication rate evaluated by a number of vessel or spinal puncture
Time frame: 5 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2017.
- 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.
Karolina Dobronska, MD principal investigator
I Department of Anaesthesiology and Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nephrolithiasis and Anesthesia, Local, run by Medical University of Warsaw at 1 site in Poland.
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: status not confirmed, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karolina Dobronska, MD (48 501323534, karolinapladzyk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effectiveness of epidural anesthesia for PNL evaluated by a number of participants having this procedure completed (time frame: 5 months). 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 28 Apr 2017.