Prospective Clinical Trial - Obturator Reflex Predictors and Blockage
Primary Purpose
Malignant Neoplasm of Urinary Bladder
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
obturator nerve block
Sponsored by
About this trial
This is an interventional treatment trial for Malignant Neoplasm of Urinary Bladder focused on measuring Transurethral resection of bladder tumors, Obturator nerve reflex, Obturator nerve block
Eligibility Criteria
Inclusion Criteria:
- Adult patient, older than 18 yo, scheduled for TUR for bladder tumor.
- The subject is willing and able to read, understand and sign the study specific informed consent form.
Exclusion Criteria:
- Patients with known coagulopathy, including patients receiving antithrombotic or thrombolytic therapy not in compliance with standard precautions.
- Patients with a known allergy to anesthetics.
- Patients who underwent partial cystectomy.
- Patients with tumors involving bladder diverticula.
- Patients with pre-existing obturator nerve injury or pre-existing neurologic deficits.
- Patients with neuromuscular disease.
- Patients with local infection above planned ONB site.
- Patients in whom the use of muscle relaxants is deemed necessary by the anesthesiologist.
- Patients with inguinal lymphadenopathy.
- Patients unable to sign an informed consent form.
Sites / Locations
- Rabin Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
uni-lateral obturator nerve block
Arm Description
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
Outcomes
Primary Outcome Measures
efficacy of obturator nerve block in preventing inadvertent obturator jerk
percentage of subjects for which the obtorator nerve block prevnted inadvertent obturator jerk
Secondary Outcome Measures
incidence rate of obturator nerve jerk reflex
frequency of obturator nerve jerk reflex
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02228330
Brief Title
Prospective Clinical Trial - Obturator Reflex Predictors and Blockage
Official Title
Prospective Clinical Trial - Obturator Reflex Predictors and Blockage
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2014 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Neoplasm of Urinary Bladder
Keywords
Transurethral resection of bladder tumors, Obturator nerve reflex, Obturator nerve block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
uni-lateral obturator nerve block
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
obturator nerve block
Intervention Description
a uni-lateral obturator nerve block will be performed under ultrasound guidance- using 2% lidocaine for obtaining a short term block.
Primary Outcome Measure Information:
Title
efficacy of obturator nerve block in preventing inadvertent obturator jerk
Description
percentage of subjects for which the obtorator nerve block prevnted inadvertent obturator jerk
Time Frame
intraoperative
Secondary Outcome Measure Information:
Title
incidence rate of obturator nerve jerk reflex
Description
frequency of obturator nerve jerk reflex
Time Frame
end of study (one year)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patient, older than 18 yo, scheduled for TUR for bladder tumor.
The subject is willing and able to read, understand and sign the study specific informed consent form.
Exclusion Criteria:
Patients with known coagulopathy, including patients receiving antithrombotic or thrombolytic therapy not in compliance with standard precautions.
Patients with a known allergy to anesthetics.
Patients who underwent partial cystectomy.
Patients with tumors involving bladder diverticula.
Patients with pre-existing obturator nerve injury or pre-existing neurologic deficits.
Patients with neuromuscular disease.
Patients with local infection above planned ONB site.
Patients in whom the use of muscle relaxants is deemed necessary by the anesthesiologist.
Patients with inguinal lymphadenopathy.
Patients unable to sign an informed consent form.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Margel, MD, PhD
Organizational Affiliation
Rabin Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petach-Tikva
ZIP/Postal Code
4941492
Country
Israel
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Prospective Clinical Trial - Obturator Reflex Predictors and Blockage
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