Malignant Neoplasm of Urinary Bladder Clinical Trial
Official title:
Prospective Clinical Trial - Obturator Reflex Predictors and Blockage
The aim of this study is to estimate the incidence rate of obturator nerve reflex and leg jerking during Transurethral Resections of Bladder Tumors (TURBTs), evaluate the efficacy of obturator nerve block in the prevention of inadvertent muscle spasm, and to identify predictors for both the jerking reflex and successful nerve block.
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
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04534075 -
Dietary Fiber During Radiotherapy - a Placebo-controlled Randomized Trial
|
Phase 3 |