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.
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
- Conditions the study is for
- Urinary Bladder Neoplasms, Transurethral Resection, Nerve Block
- 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.
Poland2 sites, 2 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| UG - ONB | Experimental | Patients 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.
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)
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
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
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.
- First posted2 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karolina Dobrońska, Medical University of Warsaw
- Investigators
- Karolina Dobronska, MD, Principal investigator, I Department of Anaesthesiology and Intensive Care
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 24578931Thallaj 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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-Guided Obturator Nerve Block for Transurethral Procedures - Interadductor Approach
- ClinicalTrials.gov ID
- NCT02696733
- Acronym / sponsor ID
- U/1/2014
- Keywords
- TURBT, ultrasound guided, ONB, interadductor approach
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Feb 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 2 Mar 2016 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UG - ONB | Experimental | Device: Ultrasound, Drug: lidocaine 2%, Drug: 0.9% Natrium Chloratum with a 2nd generation cephalosporinPatients with the bladder tumor located on the lateral wall, with the high risk of adductor muscles contraction during TURBT under spinal anesthesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- patients' refusal
- contraindications for spinal anesthesia
- skin lesions at injection site
- patients who really did not need ONB.
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 |
|---|---|---|
| UltrasoundAlso: USGUltrasound-guided obturator nerve localization | Device | UG - ONB |
| lidocaine 2%local anesthetic used to block the obturator nerve | Drug | UG - ONB |
| 0.9% Natrium Chloratum with a 2nd generation cephalosporin | Drug | UG - ONB |
Primary outcome
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
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.
3 secondary outcomes
Success rate of obturator nerve visualization with ultrasounds
Time frame: 30 months
Efficacy of ONB - measured with nerve stimulator built in the resectoscope
Time frame: 30 months
Safety of ultrasound-guided ONB measured by number of complications
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
- Background: PubMed 24578931Pladzyk 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.
- Results publication: PubMed 21655015Thallaj 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.
- Individual participant dataSharing planned: No
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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.
Karolina Dobronska, MD principal investigator
I Department of Anaesthesiology and Intensive Care
2 sites in 1 country: see every site and its status.
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.