Malignant Neoplasm of Urinary BladderNCT02228330
Prospective Clinical Trial - Obturator Reflex Predictors and Blockage
A study testing obturator nerve block in people with Malignant Neoplasm of Urinary Bladder, run by Rabin Medical Center at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Neoplasm of Urinary Bladder
- What is being tested?
- obturator nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2014to Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Malignant Neoplasm of Urinary Bladder
- Being tested
- obturator nerve block
- Keywords
- Transurethral resection of bladder tumors, Obturator nerve reflex, Obturator nerve block
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
obturator nerve blockProcedure or surgery
a uni-lateral obturator nerve block will be performed under ultrasound guidance- using 2% lidocaine for obtaining a short term block.
| Study group | Role | What they receive |
|---|---|---|
| uni-lateral obturator nerve block | Experimental | 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 Receives: Procedure: obturator nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
efficacy of obturator nerve block in preventing inadvertent obturator jerk
percentage of subjects for which the obtorator nerve block prevnted inadvertent obturator jerk
Measured: intraoperative
Secondary outcomes (1)
incidence rate of obturator nerve jerk reflex
frequency of obturator nerve jerk reflex
Measured: end of study (one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionOct 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasm of Urinary BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Margel, MD, PhD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228330
- Sponsor's protocol ID
- 0063-14-RMC
- Status last verified
- Oct 2017
- First submitted
- 4 Aug 2014
- Last updated
- 17 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Trial - Obturator Reflex Predictors and Blockage
- ClinicalTrials.gov ID
- NCT02228330
- Acronym / sponsor ID
- 0063-14-RMC
- Conditions
- Malignant Neoplasm of Urinary Bladder
- Keywords
- Transurethral resection of bladder tumors, Obturator nerve reflex, Obturator nerve block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Oct 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| uni-lateral obturator nerve block | Experimental | Procedure: obturator nerve blockPatients scheduled for TUR for bladder tumor Intervention: uni-lateral obturator nerve block. non-blocked obtorator side of each patient will be used as control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| obturator nerve blocka uni-lateral obturator nerve block will be performed under ultrasound guidance- using 2% lidocaine for obtaining a short term block. | Procedure or surgery | uni-lateral obturator nerve block |
Primary outcome
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
1 secondary outcome
incidence rate of obturator nerve jerk reflex
Time frame: end of study (one year)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Margel, MD, PhD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing obturator nerve block in people with Malignant Neoplasm of Urinary Bladder, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
efficacy of obturator nerve block in preventing inadvertent obturator jerk (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.