Bladder CancerNCT02452944
Comparison of Nerve Stimulating Approach and Interfascial Injection Approach During Sono-guided Obturator Nerve Block
A study testing nerve stimulator (stimuplex HNS12) and ultrasound in people with Bladder Cancer, run by Gachon University Gil Medical Center.
Trial summary
Transurethral resection of bladder tumor (TURB) has been essential treatment for bladder tumours. Direct electrical stimulation of an obturator nerve during the TURB procedures can trigger an inadvertent adductor muscle spasm, which can cause a serious complication like bladder perforation. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- nerve stimulator (stimuplex HNS12) and ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to May 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- all patients anticipating transurethral resection of bladder tumors with American Society of Anesthesiologists physical status(ASA) I or II
Who cannot join
- patients with diabetes or peripheral neuropathy; motor or sensory deficits in the lower extremities, ASA greater than III, coagulation disorders, anticoagulant medication, known allergy to local anesthetics, contraindications for spinal anesthesia (infection at injection site, severe scoliosis or fusion operation), uncooperative patients and patients' refusal
About this study
Official title: Comparison of Nerve Stimulating Approach and Interfascial Injection Approach During Sono-guided Obturator Nerve Block in Transurethral Resection of Bladder Tumors Under Spinal Anesthesia
Transurethral resection of bladder tumor (TURB) has been essential treatment for bladder tumours. Direct electrical stimulation of an obturator nerve during the TURB procedures can trigger an inadvertent adductor muscle spasm, which can cause a serious complication like bladder perforation.
General anesthesia with muscle relaxants for TURB does not guarantee a prevention of the adductor muscle spasm. Spinal anesthesia with selective obturator nerve block (ONB) can be an alternative anesthesia for TURB, but adductor spasm can also be induced because of incomplete ONB. Recently, ultrasound guidance with nerve stimulator has been used to enhance the safety, efficacy and shortening the onset time of ONB.
Read more
Some papers describe that comparable ONB can be done using ultrasound only without nerve stimulator, in which there is a principle that obturator nerve runs along a given pathway. Basically, obturator nerve is divided into two branches after exiting the obturator canal. The anterior branch is located in the fascial planes among adductor longus, adductor brevis and pectineus muscles, and the posterior branch is located between the adductor brevis and adductor magnus muscles at the inguinal area. But it has been known that there are many branching patterns of obturator nerve and high anatomic variability in the inguinal area in a cadaver study. And subdivisions of obturator nerve in the inguinal area have been described.
Therefore, this study was conducted to investigate the success rate of ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group) was comparable to ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) in TURB under spinal anesthesia. And we also evaluated adductor muscle twitching patterns at the inguinal region when the ONB was performed.
Read the detailed description
After obtaining approval from the Gachon Gil Hospital Ethical Committee, written informed consent was obtained from all patients anticipating TURB with American Society of Anesthesiologists physical status (ASA) I or II. Sixty two patients anticipating transurethral resection of the bladder tumors (TURB) under spinal anesthesia were enrolled in this randomized controlled trial from December 2014 to May 2015. Exclusion criteria included patients with diabetes or peripheral neuropathy; motor or sensory deficits in the lower extremities, ASA greater than III, coagulation disorders, anticoagulant medication, known allergy to local anesthetics, contraindications for spinal anesthesia (infection at injection site, severe scoliosis or fusion operation), uncooperative patients and patients' refusal. Routine monitoring was begun and Spinal anesthesia with hyperbaric 0.5% bupivacaine 12-15 mg was performed to reach the level of anesthesia, at least T10 to T4 in all patients.
Patients were then randomized into 1 of 2 groups (US-NS vs US-IFI) to receive ONB in the inguinal crease level. Randomization was performed by a computer-generated random numbers table. We counted one side obturator nerve as one, the number. Whether the right or left ONB was done, was decided by surgeon according to the tumor location. If obturator block was done in both sides, let it belong to the same group, and we counted it as two, the number.
Patients were then positioned supine, and the affected leg was slightly abducted and rotated externally without knee flexion, and the inguinal region was prepared with a povidone iodine solution. The 10 MHz linear probe (Zonare Medical Systems, California, USA) equipped with a sterile plastic cover and gel. The transducer was positioned parallel to the inguinal crease with 90° to the skin with the image depth of 4-5 cm. The inguinal region was examined laterally from the femoral vein until the 3 muscle layers consisting of the adductor longus, adductor brevis, and adductor magnus were identified with pectineus muscle medially along the inguinal crease. We allowed transducer tilting cranially 0°-20° angle until a fascial planes of the pectineus and adductor muscles were identified. A thick hyperechoic fascia was used as a targeting landmark for ONB, not focus on the obturator nerve itself (One between adductor longus and adductor brevis muscles for anterior branch, another between adductor brevis and adductor magnus muscles for posterior branch of obturator nerve). We excluded the case, in which three muscle layers were not identified definitely within the range.
In the US-NS group, 22-gauge, 120-mm stimulating needle (Stimuplex insulated needle; D Plus B. Braun, Melsungen, Germany) attached to a nerve stimulator (Stimuplex HNS12;B. Braun, Melsungen, Germany) advanced via an ultrasound in-plane approach from lateral to medical direction to position the needle tip on the anterior branch. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics (LA; 1.5% lidocaine + epi 1:200,000) were slowly injected within the muscle interface after negative aspiration, resulting in separation of these two muscles under real-time visualization. If there was misdistribution of LA spread (eg, spread into the muscle tissue), the needle was redirected until the correct spread of LA was visualized. The needle was withdrawn to the skin and reinserted to position the needle tip on the posterior branch. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected. After injection to the anterior and posterior branch, the stimulation current increased 1.0 mA, and needle was re-advanced as like Fig 1d for searching the residual muscle twitching. If muscle twitching was observed, then current was decreased to 0.5 mA, and confirming the muscle twitching on the sonogram at that current, 5ml of LA injected. We wrote that muscle twitching was occurred in what kind of muscles or fascias.
In the US-IFI group, 22-gauge, 120-mm stimulating needle (Stimuplex insulated needle; D Plus B. Braun, Melsungen, Germany) without nerve stimulator advanced via an ultrasound in-plane approach from lateral to medical direction to position the needle tip on anterior branch. After negative aspiration, 10mL of LA were slowly injected within the muscle interface, resulting in separation of these two muscles under real-time visualization. The needle was withdrawn to the skin and reinserted to position the needle tip on posterior branch, another 5mL of LA was injected. After that, the needle was withdrawn to the skin and reinserted to the same spots, attached with nerve stimulator at the stimulation current 1.0 mA for confirming the block of anterior and posterior branch. If adductor muscle twitching was shown on sonogram, another 5mL of LA was injected, and it was documented as 'fail'. After that, needle was re-advanced as like US-NS group for searching the residual muscle twitching. It then went through the same process as the US-NS group, and we wrote that muscle twitching was occurred in what kind of muscles or fascias. We used only the nerve stimulator for confirming the success or fail of the ONB before the TURB surgery.
Any needle redirection after withdrawing to the skin, was recorded as an additional needle pass. Before the injection, the image was captured as static, and the depth of anterior and posterior branch was measured by use of the built-in caliper of the ultrasound machine. We recorded ONB time, and time from the start of the sonographic examination until muscle layers identification was included. All blocks were performed by one anesthesiologist with more than 60 ONB experiences.
After performing the ONB, patients were positioned in lithotomy position. Endoscopic resection of the neoplasm was started using a bipolar resectoscope (electrical current: 280 W) and endovesical irrigation with a normal saline solution. The surgery was performed by six surgeons randomly. We requested two assistants of urology, who didn't know the study groups (US-NS vs US-IFI) for obturator reflex grading. Obturator reflex grade was assessed by the scale of Lee's paper. Gr I: no movement or palpable muscle twitching, Gr II: palpable muscle twitching without movement, Gr III: slight movement of the thigh not interfering with the surgical procedure, and Gr IV: vigorous movement interfering with the surgical procedure.
- Conditions
- Bladder Cancer
- Being tested
- nerve stimulator (stimuplex HNS12), ultrasound
- Keywords
- nerve stimulator, obturator nerve, ultrasound
- 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.
nerve stimulator (stimuplex HNS12)Device
whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block
ultrasoundDevice
we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerve run.
| Study group | Role | What they receive |
|---|---|---|
| US-IFI group | Experimental | ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)
The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis muscles. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected.
After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as 'fail'. Receives: Device: nerve stimulator (stimuplex HNS12); Device: ultrasound |
| US-NS group | Active comparator | ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis muscles. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected. Receives: Device: nerve stimulator (stimuplex HNS12); Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Group
We used only the nerve stimulator for confirming the success or fail of the ONB before the surgery, so we assumed that the US-NS group had complete ONB in all patients.
In US-IFI group, complete ONB was confirmed with nerve stimulator at the end of the procedure, and if the residual twitching remained, the case was considered to be a 'fail'.
Measured: up to 8 weeks
Secondary outcomes (1)
Count the Number of Sub-divisions of Obturator Nerve at the Inguinal Crease
We checked the additional intramuscular twitching with at least 3 times more needling after block the anterior and posterior branches in both groups. And documented that twitching occurred in what kind of muscles.
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startDec 2014
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mi Geum Lee, Gachon University Gil Medical Center
- Investigators
- Mi Geum Lee, MD, PhD, Study director, Gachon University Gil Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452944
- Sponsor's protocol ID
- GAIRB2014-337
- Status last verified
- Jan 2016
- First submitted
- 7 May 2015
- Last updated
- 8 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Anagnostopoulou S, Kostopanagiotou G, Paraskeuopoulos T, Chantzi C, Lolis E, Saranteas T. Anatomic variations of the obturator nerve in the inguinal region: implications in conventional and ultrasound regional anesthesia techniques. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):33-9. doi: 10.1097/AAP.0b013e3181933b51.
PubMed 19258986
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nerve Stimulating Approach and Interfascial Injection Approach During Sono-guided Obturator Nerve Block in Transurethral Resection of Bladder Tumors Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT02452944
- Acronym / sponsor ID
- GAIRB2014-337
- Conditions
- Bladder Cancer
- Keywords
- nerve stimulator, obturator nerve, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Gachon University Gil Medical CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Posted 23 Jul 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Transurethral resection of bladder tumor (TURB) has been essential treatment for bladder tumours. Direct electrical stimulation of an obturator nerve during the TURB procedures can trigger an inadvertent adductor muscle spasm, which can cause a serious complication like bladder perforation.
General anesthesia with muscle relaxants for TURB does not guarantee a prevention of the adductor muscle spasm. Spinal anesthesia with selective obturator nerve block (ONB) can be an alternative anesthesia for TURB, but adductor spasm can also be induced because of incomplete ONB. Recently, ultrasound guidance with nerve stimulator has been used to enhance the safety, efficacy and shortening the onset time of ONB.
Some papers describe that comparable ONB can be done using ultrasound only without nerve stimulator, in which there is a principle that obturator nerve runs along a given pathway. Basically, obturator nerve is divided into two branches after exiting the obturator canal. The anterior branch is located in the fascial planes among adductor longus, adductor brevis and pectineus muscles, and the posterior branch is located between the adductor brevis and adductor magnus muscles at the inguinal area. But it has been known that there are many branching patterns of obturator nerve and high anatomic variability in the inguinal area in a cadaver study. And subdivisions of obturator nerve in the inguinal area have been described.
Therefore, this study was conducted to investigate the success rate of ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group) was comparable to ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) in TURB under spinal anesthesia. And we also evaluated adductor muscle twitching patterns at the inguinal region when the ONB was performed.
Detailed description
After obtaining approval from the Gachon Gil Hospital Ethical Committee, written informed consent was obtained from all patients anticipating TURB with American Society of Anesthesiologists physical status (ASA) I or II. Sixty two patients anticipating transurethral resection of the bladder tumors (TURB) under spinal anesthesia were enrolled in this randomized controlled trial from December 2014 to May 2015. Exclusion criteria included patients with diabetes or peripheral neuropathy; motor or sensory deficits in the lower extremities, ASA greater than III, coagulation disorders, anticoagulant medication, known allergy to local anesthetics, contraindications for spinal anesthesia (infection at injection site, severe scoliosis or fusion operation), uncooperative patients and patients' refusal. Routine monitoring was begun and Spinal anesthesia with hyperbaric 0.5% bupivacaine 12-15 mg was performed to reach the level of anesthesia, at least T10 to T4 in all patients.
Patients were then randomized into 1 of 2 groups (US-NS vs US-IFI) to receive ONB in the inguinal crease level. Randomization was performed by a computer-generated random numbers table. We counted one side obturator nerve as one, the number. Whether the right or left ONB was done, was decided by surgeon according to the tumor location. If obturator block was done in both sides, let it belong to the same group, and we counted it as two, the number.
Patients were then positioned supine, and the affected leg was slightly abducted and rotated externally without knee flexion, and the inguinal region was prepared with a povidone iodine solution. The 10 MHz linear probe (Zonare Medical Systems, California, USA) equipped with a sterile plastic cover and gel. The transducer was positioned parallel to the inguinal crease with 90° to the skin with the image depth of 4-5 cm. The inguinal region was examined laterally from the femoral vein until the 3 muscle layers consisting of the adductor longus, adductor brevis, and adductor magnus were identified with pectineus muscle medially along the inguinal crease. We allowed transducer tilting cranially 0°-20° angle until a fascial planes of the pectineus and adductor muscles were identified. A thick hyperechoic fascia was used as a targeting landmark for ONB, not focus on the obturator nerve itself (One between adductor longus and adductor brevis muscles for anterior branch, another between adductor brevis and adductor magnus muscles for posterior branch of obturator nerve). We excluded the case, in which three muscle layers were not identified definitely within the range.
In the US-NS group, 22-gauge, 120-mm stimulating needle (Stimuplex insulated needle; D Plus B. Braun, Melsungen, Germany) attached to a nerve stimulator (Stimuplex HNS12;B. Braun, Melsungen, Germany) advanced via an ultrasound in-plane approach from lateral to medical direction to position the needle tip on the anterior branch. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics (LA; 1.5% lidocaine + epi 1:200,000) were slowly injected within the muscle interface after negative aspiration, resulting in separation of these two muscles under real-time visualization. If there was misdistribution of LA spread (eg, spread into the muscle tissue), the needle was redirected until the correct spread of LA was visualized. The needle was withdrawn to the skin and reinserted to position the needle tip on the posterior branch. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected. After injection to the anterior and posterior branch, the stimulation current increased 1.0 mA, and needle was re-advanced as like Fig 1d for searching the residual muscle twitching. If muscle twitching was observed, then current was decreased to 0.5 mA, and confirming the muscle twitching on the sonogram at that current, 5ml of LA injected. We wrote that muscle twitching was occurred in what kind of muscles or fascias.
In the US-IFI group, 22-gauge, 120-mm stimulating needle (Stimuplex insulated needle; D Plus B. Braun, Melsungen, Germany) without nerve stimulator advanced via an ultrasound in-plane approach from lateral to medical direction to position the needle tip on anterior branch. After negative aspiration, 10mL of LA were slowly injected within the muscle interface, resulting in separation of these two muscles under real-time visualization. The needle was withdrawn to the skin and reinserted to position the needle tip on posterior branch, another 5mL of LA was injected. After that, the needle was withdrawn to the skin and reinserted to the same spots, attached with nerve stimulator at the stimulation current 1.0 mA for confirming the block of anterior and posterior branch. If adductor muscle twitching was shown on sonogram, another 5mL of LA was injected, and it was documented as 'fail'. After that, needle was re-advanced as like US-NS group for searching the residual muscle twitching. It then went through the same process as the US-NS group, and we wrote that muscle twitching was occurred in what kind of muscles or fascias. We used only the nerve stimulator for confirming the success or fail of the ONB before the TURB surgery.
Any needle redirection after withdrawing to the skin, was recorded as an additional needle pass. Before the injection, the image was captured as static, and the depth of anterior and posterior branch was measured by use of the built-in caliper of the ultrasound machine. We recorded ONB time, and time from the start of the sonographic examination until muscle layers identification was included. All blocks were performed by one anesthesiologist with more than 60 ONB experiences.
After performing the ONB, patients were positioned in lithotomy position. Endoscopic resection of the neoplasm was started using a bipolar resectoscope (electrical current: 280 W) and endovesical irrigation with a normal saline solution. The surgery was performed by six surgeons randomly. We requested two assistants of urology, who didn't know the study groups (US-NS vs US-IFI) for obturator reflex grading. Obturator reflex grade was assessed by the scale of Lee's paper. Gr I: no movement or palpable muscle twitching, Gr II: palpable muscle twitching without movement, Gr III: slight movement of the thigh not interfering with the surgical procedure, and Gr IV: vigorous movement interfering with the surgical procedure.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US-IFI group | Experimental | Device: nerve stimulator (stimuplex HNS12), Device: ultrasoundultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group) The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis muscles. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected. After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as 'fail'. |
| US-NS group | Active comparator | Device: nerve stimulator (stimuplex HNS12), Device: ultrasoundultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis muscles. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients anticipating transurethral resection of bladder tumors with American Society of Anesthesiologists physical status(ASA) I or II
Key exclusion criteria (1 listed)
- patients with diabetes or peripheral neuropathy; motor or sensory deficits in the lower extremities, ASA greater than III, coagulation disorders, anticoagulant medication, known allergy to local anesthetics, contraindications for spinal anesthesia (infection at injection site, severe scoliosis or fusion operation), uncooperative patients and patients' refusal
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 |
|---|---|---|
| nerve stimulator (stimuplex HNS12)whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block | Device | US-IFI group, US-NS group |
| ultrasoundwe did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerve run. | Device | US-IFI group, US-NS group |
Primary outcome
Success Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Group
Time frame: up to 8 weeks
We used only the nerve stimulator for confirming the success or fail of the ONB before the surgery, so we assumed that the US-NS group had complete ONB in all patients. In US-IFI group, complete ONB was confirmed with nerve stimulator at the end of the procedure, and if the residual twitching remained, the case was considered to be a 'fail'.
1 secondary outcome
Count the Number of Sub-divisions of Obturator Nerve at the Inguinal Crease
Time frame: up to 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19258986Anagnostopoulou S, Kostopanagiotou G, Paraskeuopoulos T, Chantzi C, Lolis E, Saranteas T. Anatomic variations of the obturator nerve in the inguinal region: implications in conventional and ultrasound regional anesthesia techniques. Reg Anesth Pain Med. 2009 Jan-Feb;34(1):33-9. doi: 10.1097/AAP.0b013e3181933b51.
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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.
Mi Geum Lee, MD, PhD study director
Gachon University Gil Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing nerve stimulator (stimuplex HNS12) and ultrasound in people with Bladder Cancer, run by Gachon University Gil Medical Center.
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 1 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 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 23 Jul 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Success Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Group (time frame: up to 8 weeks). 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 NCT02452944, which also lists 1 linked publication.
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 8 Feb 2016; AzTrials last refreshed its copy on 7 Nov 2026.