Prospective Clinical Trial - Obturator Reflex Predictors and Blockage
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|ClinicalTrials.gov Identifier: NCT02228330|
Recruitment Status : Unknown
Verified October 2017 by Rabin Medical Center.
Recruitment status was: Enrolling by invitation
First Posted : August 29, 2014
Last Update Posted : October 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Malignant Neoplasm of Urinary Bladder||Procedure: obturator nerve block||Not Applicable|
Study design: A single center single arm prospective study aiming to estimate the incidence rate of obturator nerve reflex and leg jerking during TURBTs, evaluate the efficacy of obturator nerve block (ONB) in the prevention of inadvertent muscle spasm, and identify predictors for both the jerking reflex and successful nerve block.
Study population: patients who are scheduled for TUR for bladder tumor, as standard care, who are willing and able to participate in the study
Intervention: a uni-lateral ONB (using Lidocaine 2%)
Study outline: Once in the operating room patients will be monitored by continuous electrocardiography, non-invasive arterial blood pressure measurement, and pulse oximetry in the usual manner. They will then undergo general or spinal anesthesia according to their preference and at the discretion of the treating anesthesiologist, without the use of muscle relaxants. As part of the study, a uni-lateral ONB will be performed under ultrasound guidance- using 2% lidocaine for obtaining a short term block, for the duration of the procedure itself. The non-blocked nerve will be used as control. The surgeon will be blinded as to the side in which the ONB has been performed. A catheter will be used to fill the bladder with saline to its full capacity. The inner wall of the bladder will then be stimulated to test for an obturator nerve reflex and leg jerking. Stimulation will be done using a trans-resectoscope and a single-twitch electrical current generated by a neuromuscular monitoring device, as previously described by Mihara et al. Four different bladder volumes will be tested. For each bladder volume, a reflex response on both sides will be documented and graded. The investigators will then proceed with a TUR in the usual manner.
Primary endpoints: frequency of obturator jerk reflex and efficacy of obturator nerve block
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Prospective Clinical Trial - Obturator Reflex Predictors and Blockage|
|Study Start Date :||July 2014|
|Estimated Primary Completion Date :||October 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: uni-lateral obturator nerve block
Patients scheduled for TUR for bladder tumor Intervention: uni-lateral obturator nerve block.
non-blocked obtorator side of each patient will be used as control
Procedure: obturator nerve block
a uni-lateral obturator nerve block will be performed under ultrasound guidance- using 2% lidocaine for obtaining a short term block.
- efficacy of obturator nerve block in preventing inadvertent obturator jerk [ Time Frame: intraoperative ]percentage of subjects for which the obtorator nerve block prevnted inadvertent obturator jerk
- incidence rate of obturator nerve jerk reflex [ Time Frame: end of study (one year) ]frequency of obturator nerve jerk reflex
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228330
|Rabin Medical Center|
|Petach-Tikva, Israel, 4941492|
|Principal Investigator:||David Margel, MD, PhD||Rabin Medical Center|