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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
Sponsor:
Information provided by (Responsible Party):
Rabin Medical Center

Tracking Information
First Submitted Date  ICMJE August 4, 2014
First Posted Date  ICMJE August 29, 2014
Last Update Posted Date October 17, 2017
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02228330 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 28, 2014)
incidence rate of obturator nerve jerk reflex [ Time Frame: end of study (one year) ]
frequency of obturator nerve jerk reflex
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prospective Clinical Trial - Obturator Reflex Predictors and Blockage
Official Title  ICMJE Prospective Clinical Trial - Obturator Reflex Predictors and Blockage
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Malignant Neoplasm of Urinary Bladder
Intervention  ICMJE 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.
Study Arms  ICMJE 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

Intervention: Procedure: obturator nerve block
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 28, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02228330
Other Study ID Numbers  ICMJE 0063-14-RMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Rabin Medical Center
Study Sponsor  ICMJE Rabin Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: David Margel, MD, PhD Rabin Medical Center
PRS Account Rabin Medical Center
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP