Bladder InjuryNCT01547637
Preventing the Obturator Nerve Reflex
A study testing Obturator nerve block in people with Bladder Injury, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The key objective of this study is to compare success rates of ultrasound guided obturator nerve block and anatomic landmark guided obturator nerve block as determined by neuromonitoring endpoints and surgeon observations. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Bladder Injury
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Aug 2017
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing TURBT for lateral wall bladder tumors at risk for electrical stimulation as determined by the attending surgeon.
Who cannot join
- Pre-existing obturator nerve injury
- Thigh adductor muscle weakness
- Neuropathy
- Local anesthetic allergy
- Infection at the site of injection
- Abnormal coagulation studies
- use of neuromuscular blocking medications (if deemed necessary by attending anesthesiologist caring for the patient).
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Preventing the Obturator Nerve Reflex: A Comparison of Ultrasound Guided Obturator Nerve Block and Classic Anatomic Block Technique.
The key objective of this study is to compare success rates of ultrasound guided obturator nerve block and anatomic landmark guided obturator nerve block as determined by neuromonitoring endpoints and surgeon observations.
Read the detailed description
Transurethral resection of bladder tumor (TURBT) is a urologic surgery used in the treatment of non-muscle invasive bladder cancer. A potential complication of this procedure is bladder rupture or injury secondary to adductor muscle contraction from obturator nerve stimulation. This risk is increased in resection of lateral wall tumors, as electrosurgical resection of these lesions is more likely to inadvertently stimulate the obturator nerve.
There are several mechanisms for preventing the obturator reflex. Pharmacologic paralysis can reliably inhibit thigh adduction. However, TURBT is often a short procedure that is not amendable to intermediate duration neuromuscular blocking medications. The use of succinylcholine is another option but is limited by its short duration of action which may not be adequate for the time needed to resect the tumor. Additionally, many patients have contraindications to the use of succinylcholine. Spinal anesthesia does not reliably prevent the obturator reflex.
Regional anesthesia is another potential treatment modality to prevent the obturator reflex during TURBT. Motor blockade of the obturator nerve will prevent this adduction in the event of inadvertent nerve stimulation. Peripheral blockade of the obturator nerve can be combined with either general or spinal anesthesia. Historically, obturator nerve block (ONB) has been considered a technically challenging procedure. Recently, however, successful ultrasound guided ONB techniques have been reported. To the best of our knowledge there has been no study to date comparing the effectiveness of ONB achieved by anatomic landmarks (with nerve stimulation) versus ultrasound guided ONB (with nerve stimulation) at preventing the obturator reflex during TURBT surgery.
The key objective of this study is to compare success rates of ultrasound guided obturator nerve block and anatomic guided obturator nerve block as determined by neuromonitoring endpoints and surgeon observations.
- Conditions
- Bladder Injury
- Being tested
- Obturator nerve block
- Keywords
- Obturator nerve block, Regional anesthesia, TURBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obturator nerve blockProcedure or surgery
Also called anatomic obturator block
Peripheral obturator nerve block using 10 ml of 2% lidocaine
Obturator nerve blockProcedure or surgery
Also called ultrasound guided obturator nerve block
Ultrasound guided peripheral obturator nerve block
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound Guided | Experimental | Ultrasound guided obturator nerve block will be performed after induction of general anesthesia. The anterior and posterior divisions of the obturator nerve will be identified with ultrasound. A stimulating needle will be inserted under direct ultrasound visualization. The anterior division will be blocked first. When adductor twitches are present at less than or equal to 0.5 mA, 10 ml of 2% lidocaine will be injected. Next, the needle will be re-directed under direct ultrasound visualization towards the posterior branch of the obturator nerve. After twitches < 0.5 mA are achieved then 10 mL of 2% lidocaine will be injected when the needle tip is visualized in proximity of the posterior branch. Receives: Procedure: Obturator nerve block |
| Anatomic landmark | Experimental | Obturator nerve block will be performed after induction of general anesthesia. The adductor magnus tendon approach will be used. A 4 cm insulated stimulating needle will be used to verify location of the obturator nerve by contraction of the thigh adductor group. The needle will be advanced until nerve stimulation is still present at less than or equal to 0.5 mA. When the appropriate nerve stimulation is achieved 10 ml of 2% lidocaine will be injected in divided doses with frequent aspiration. Nerve conduction studies will be repeated once a minute for the first 10 minutes after block completion. Receives: Procedure: Obturator nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nerve conduction velocity
Neuromonitoring technician will measure and record obturator nerve conduction velocity in pre-defined time intervals after performance of obturator nerve block.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2012 (estimated)
- Study startMay 2012
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder InjuryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan Anson, Milton S. Hershey Medical Center
- Investigators
- Jonathan A Anson, MD, Principal investigator, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547637
- Sponsor's protocol ID
- PRAMS039186EP
- Status last verified
- May 2018
- First submitted
- 29 Feb 2012
- Last updated
- 31 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing the Obturator Nerve Reflex: A Comparison of Ultrasound Guided Obturator Nerve Block and Classic Anatomic Block Technique.
- ClinicalTrials.gov ID
- NCT01547637
- Acronym / sponsor ID
- PRAMS039186EP
- Conditions
- Bladder Injury
- Keywords
- Obturator nerve block, Regional anesthesia, TURBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 8 Mar 2012 (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 key objective of this study is to compare success rates of ultrasound guided obturator nerve block and anatomic landmark guided obturator nerve block as determined by neuromonitoring endpoints and surgeon observations.
Detailed description
Transurethral resection of bladder tumor (TURBT) is a urologic surgery used in the treatment of non-muscle invasive bladder cancer. A potential complication of this procedure is bladder rupture or injury secondary to adductor muscle contraction from obturator nerve stimulation. This risk is increased in resection of lateral wall tumors, as electrosurgical resection of these lesions is more likely to inadvertently stimulate the obturator nerve.
There are several mechanisms for preventing the obturator reflex. Pharmacologic paralysis can reliably inhibit thigh adduction. However, TURBT is often a short procedure that is not amendable to intermediate duration neuromuscular blocking medications. The use of succinylcholine is another option but is limited by its short duration of action which may not be adequate for the time needed to resect the tumor. Additionally, many patients have contraindications to the use of succinylcholine. Spinal anesthesia does not reliably prevent the obturator reflex.
Regional anesthesia is another potential treatment modality to prevent the obturator reflex during TURBT. Motor blockade of the obturator nerve will prevent this adduction in the event of inadvertent nerve stimulation. Peripheral blockade of the obturator nerve can be combined with either general or spinal anesthesia. Historically, obturator nerve block (ONB) has been considered a technically challenging procedure. Recently, however, successful ultrasound guided ONB techniques have been reported. To the best of our knowledge there has been no study to date comparing the effectiveness of ONB achieved by anatomic landmarks (with nerve stimulation) versus ultrasound guided ONB (with nerve stimulation) at preventing the obturator reflex during TURBT surgery.
The key objective of this study is to compare success rates of ultrasound guided obturator nerve block and anatomic guided obturator nerve block as determined by neuromonitoring endpoints and surgeon observations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound Guided | Experimental | Procedure: Obturator nerve blockUltrasound guided obturator nerve block will be performed after induction of general anesthesia. The anterior and posterior divisions of the obturator nerve will be identified with ultrasound. A stimulating needle will be inserted under direct ultrasound visualization. The anterior division will be blocked first. When adductor twitches are present at less than or equal to 0.5 mA, 10 ml of 2% lidocaine will be injected. Next, the needle will be re-directed under direct ultrasound visualization towards the posterior branch of the obturator nerve. After twitches < 0.5 mA are achieved then 10 mL of 2% lidocaine will be injected when the needle tip is visualized in proximity of the posterior branch. |
| Anatomic landmark | Experimental | Procedure: Obturator nerve blockObturator nerve block will be performed after induction of general anesthesia. The adductor magnus tendon approach will be used. A 4 cm insulated stimulating needle will be used to verify location of the obturator nerve by contraction of the thigh adductor group. The needle will be advanced until nerve stimulation is still present at less than or equal to 0.5 mA. When the appropriate nerve stimulation is achieved 10 ml of 2% lidocaine will be injected in divided doses with frequent aspiration. Nerve conduction studies will be repeated once a minute for the first 10 minutes after block completion. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing TURBT for lateral wall bladder tumors at risk for electrical stimulation as determined by the attending surgeon.
Key exclusion criteria (7 listed)
- Pre-existing obturator nerve injury
- Thigh adductor muscle weakness
- Neuropathy
- Local anesthetic allergy
- Infection at the site of injection
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 blockAlso: anatomic obturator blockPeripheral obturator nerve block using 10 ml of 2% lidocaine | Procedure or surgery | Anatomic landmark |
| Obturator nerve blockAlso: ultrasound guided obturator nerve blockUltrasound guided peripheral obturator nerve block | Procedure or surgery | Ultrasound Guided |
Primary outcome
Nerve conduction velocity
Time frame: 1 day
Neuromonitoring technician will measure and record obturator nerve conduction velocity in pre-defined time intervals after performance of obturator nerve block.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2018.
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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.
Jonathan A Anson, MD principal investigator
Milton S. Hershey 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 Bladder Injury, run by Milton S. Hershey Medical Center at 1 site in United States.
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 1 inclusion and 7 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: finished, as of the sponsor's last update on 31 May 2018. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nerve conduction velocity (time frame: 1 day). 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 31 May 2018.