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 Overview

• Status: Unknown
• Conditions: Malignant Neoplasm of Urinary Bladder
• Intervention / Treatment: Procedure: obturator 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: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petach-Tikva, Israel, 4941492
    • Rabin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
efficacy of obturator nerve block in preventing inadvertent obturator jerk	percentage of subjects for which the obtorator nerve block prevnted inadvertent obturator jerk	intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence rate of obturator nerve jerk reflex	frequency of obturator nerve jerk reflex	end of study (one year)

Collaborators and Investigators

• Sponsor: Rabin Medical Center

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): October 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: August 4, 2014
• First Submitted That Met QC Criteria: August 28, 2014
• First Posted (Estimate): August 29, 2014

Study Record Updates

• Last Update Posted (Actual): October 17, 2017
• Last Update Submitted That Met QC Criteria: October 15, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Obturator nerve block; Transurethral resection of bladder tumors; Obturator nerve reflex
• Additional Relevant MeSH Terms: Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Neoplasms; Urinary Bladder Neoplasms
• Other Study ID Numbers: 0063-14-RMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED