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Urinary Bladder NeoplasmsPhase 4NCT02696733

Ultrasound-Guided ONB for Transurethral Procedures - Interadductor Approach

A Phase 4 study testing Ultrasound, lidocaine 2% and 0.9% Natrium Chloratum with a 2nd generation cephalosporin in people with Urinary Bladder Neoplasms and Transurethral Resection, run by Medical University of Warsaw at 2 sites in Poland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Obturator nerve block is an effective method to prevent adductor muscles contraction during transurethral resection of bladder tumour localized on the lateral wall. Due to prior spinal anaesthesia the patient does not feel uncomfortable during the blockade and the interadductor approach gives the possibility to… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ultrasound, lidocaine 2% and 0.9% Natrium Chloratum with a 2nd generation cephalosporin
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
2 sitesPoland
Study dates
Feb 2016to Dec 2017
Phase
Phase 4
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

  • informed consent
  • bladder tumor located on the lateral wall
  • transurethral resection of the bladder tumor
  • urologist decision that there is a risk of the stimulation of obturator nerve during resection
  • spinal anesthesia

Who cannot join

  • patients' refusal
  • contraindications for spinal anesthesia
  • skin lesions at injection site
  • patients who really did not need ONB.

Trial locations and contacts

2 sites in 1 country.

Karolina Dobronska, MD contact

+48 22 502 17 27

karolinapladzyk@gmail.com

Lidia I Jureczko, PhD MD contact

+48 22 502 17 27

jureczko@gmail.com

Poland2 sites, 2 recruiting
  • I Department od Anaesthesiology and Intensive Care

    Warsaw, 02-005

    Karolina Dobronska, MD, +48 22 501 17 27, karolinapladzyk@gmail.com

    Lidia I Jureczko, PhD MD, +48 22 501 17 27, jureczko@gmail.com

    Recruiting
  • I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw

    Warsaw, 02-005

    Karolina Dobronska, MD, +48 22 501 17 27, karolinapladzyk@gmail.com

    Lidia I Jureczko, PhD MD, +48 22 501 17 27, jureczko@gmail.com

    Recruiting

Other trials in Poland

About this study

Official title: Ultrasound-Guided Obturator Nerve Block for Transurethral Procedures - Interadductor Approach

Obturator nerve block is an effective method to prevent adductor muscles contraction during transurethral resection of bladder tumour localized on the lateral wall. Due to prior spinal anaesthesia the patient does not feel uncomfortable during the blockade and the interadductor approach gives the possibility to perform it in the lithotomy position. The aim of the study was to evaluate the safety and effectiveness of ultrasound-guided obturator nerve identification and blockade for TURBT.

Read the detailed description

The basic methods for diagnosis and management of bladder cancer are endoscopic procedures. Transurethral resection of bladder tumor (TURBT) is usually performed under spinal anesthesia that does not prevent an unintended stimulation of the obturator nerve (ON) when electroresection is performed on the lateral wall of the bladder. This sensorimotor nerve arises from the lumbar plexus at L2-L4. It innervates the muscles responsible for adducting the thigh and the skin on the surface of the paramedian segment of the thigh. During TURBT, when the bladder has been filled with irrigation fluid, the ON is directly adjacent to the lateral wall of the bladder and it can be stimulated during the electroresection. Sudden contraction of the adductor muscles of the thigh, may lead to perforation of bladder wall with the resectoscope loop.

In the Department of General, Oncologic and Functional Urology, Medical University of Warsaw approximately 500 TURBT are performed every year; 7% of them necessitate the prevention of ON stimulation. Anesthetists perform obturator nerve block (ONB) - the anterior branch, using the stimulator for the identification with the 94% efficacy.

Recently, ultrasound guidance has been used to enhance the safety and efficacy of the nerve blocks that is why we have decided to evaluate the effectiveness of ONB performed with ultrasounds.

An approval from the Medical University of Warsaw Bioethical Committee has been obtained. Patients need to give written informed consent to participate in the study.

It is anticipated that 100 patients with TURBT performed under spinal anesthesia that, after the urologist decision, necessitate the ONB will be enrolled in this study.

Before the procedure an oral premedication is given. After admission to the operating room, intravenous access is established and the patient receives a drip infusion of 500 ml 0.9% Natrium Chloratum with an antibiotic (2nd generation cephalosporin). Constant monitoring is ensured of ECG, heart rate, and pulse oxymetry. Non-invasive blood pressure measurement is taken every five minutes. To maintain patients' blood oxygenation, oxygen is delivered with the use of a facemask. Spinal anesthesia is performed with patients in the sitting position, most frequently in the L3 L4 space (in the case of technical difficulties - L2 L3 or L4 L5) using 8-15 mg 0.5% hyperbaric bupivacaine depending on the patient's anthropometric parameters. The needles used are 25-27G pencil point. After drug administration, the patient is placed in the supine position.

Upon reaching the appropriate anesthesia level (Th10), which blocks conduction in the sensory nerve fibers of the bladder, the patient is placed in the lithotomy position. In the case of tumors located on the lateral wall of the bladder, the safety of TURBT is ensured using a neurotest performed by an urologist with a nerve stimulator built into the resectoscope (Neurotester FB2, ERBE). The extremity movement leads to the decision to block the ON.

Ultrasound-guided ONB procedure:

The patient remains in the lithotomy position. For nerve identification a linear transducer is used. It is placed next to the grain to visualize three adductor muscles. Between adductor longus and adductor brevis, in fascial plane, an anterior branch of obturator should be visualized. The needle is advanced toward the nerve in an out-of-plane trajectory. The local anesthetic is injected after heme-negative aspiration. The resistance during injection is avoided to reduce the risk of intraneural injection. If there are problems with nerve identification the anesthetic is injected in fascial plane between adductors muscles - longus and brevis.

10 ml of 2% lidocaine is used for single block and 2 x 10 ml of 2% lidocaine with epinephrine when bilateral one is needed.

Before TURBT starts again, the urologist once more perform the neurotest to evaluate the ONB efficacy.

After enrolling 50 patients to the study the results will be evaluated and the decision whether to decrease the amount of 10 ml of 2% lidocaine for injection will be taken.

Being tested
Ultrasound, lidocaine 2%, 0.9% Natrium Chloratum with a 2nd generation cephalosporin
Keywords
TURBT, ultrasound guided, ONB, interadductor approach
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.

  • UltrasoundDevice

    Also called USG

    Ultrasound-guided obturator nerve localization

  • lidocaine 2%Drug

    local anesthetic used to block the obturator nerve

  • 0.9% Natrium Chloratum with a 2nd generation cephalosporinDrug

Study groups in NCT02696733
Study groupRoleWhat they receive
UG - ONBExperimentalPatients with the bladder tumor located on the lateral wall, with the high risk of adductor muscles contraction during TURBT under spinal anesthesia.
Receives: Device: Ultrasound; Drug: lidocaine 2%; Drug: 0.9% Natrium Chloratum with a 2nd generation cephalosporin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effectiveness of ultrasound guided obturator nerve block - evaluated by a number of participants having transurethral resection of bladder tumor without unintended obturator nerve stimulation.

    The investigator evaluates whether the urologist was able to perform safe electroresection of bladder tumor with no extremity movement. All extremity movements due to obturator nerve stimulation and all necessities to perform general anesthesia will be counted as unsuccessful ultrasound - guided ONB.

    Measured: 30 months

Secondary outcomes (3)
  1. Success rate of obturator nerve visualization with ultrasounds

    The investigators evaluate whether it was possible to visualize the obturator nerve in the fascial plane

    Measured: 30 months

  2. Efficacy of ONB - measured with nerve stimulator built in the resectoscope

    A nerve stimulator (Neurotester FB2, ERBE) is used to evaluate the efficacy of the nerve block. Current flow settings are progressively marked relative to a 1-5 scale .

    Measured: 30 months

  3. Safety of ultrasound-guided ONB measured by number of complications

    hematoma , lidocaine overdose symptoms, bladder perforation,obturator nerve injury

    Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionDec 2017 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02696733
Sponsor's protocol ID
U/1/2014
Status last verified
Jul 2017
First submitted
22 Feb 2016
Last updated
18 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Pladzyk K, Jureczko L, Lazowski T. Over 500 obturator nerve blocks in the lithotomy position during transurethral resection of bladder tumor. Cent European J Urol. 2012;65(2):67-70. doi: 10.5173/ceju.2012.02.art2. Epub 2012 Jun 12.

    PubMed 24578931
  • Thallaj A, Rabah D. Efficacy of ultrasound-guided obturator nerve block in transurethral surgery. Saudi J Anaesth. 2011 Jan;5(1):42-4. doi: 10.4103/1658-354X.76507.

    PubMed 21655015

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ultrasound, lidocaine 2% and 0.9% Natrium Chloratum with a 2nd generation cephalosporin in people with Urinary Bladder Neoplasms and Transurethral Resection, run by Medical University of Warsaw at 2 sites in Poland.

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 5 inclusion and 4 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 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Poland. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Contact Karolina Dobronska, MD (+48 22 502 17 27, karolinapladzyk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effectiveness of ultrasound guided obturator nerve block - evaluated by a number of participants having transurethral resection of bladder tumor without unintended obturator nerve stimulation. (time frame: 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02696733, which also lists 2 linked publications.

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 18 Jul 2017.

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