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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02986997
Other study ID # U/1/2016
Secondary ID
Status Recruiting
Phase N/A
First received December 6, 2016
Last updated April 27, 2017
Start date December 2016
Est. completion date September 2017

Study information

Verified date April 2017
Source Medical University of Warsaw
Contact Karolina Dobronska, MD
Phone 48 501323534
Email karolinapladzyk@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date September 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- PNL procedure

Exclusion Criteria:

- no PNL procedure

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 5 months
Secondary 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 5 months
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