Bladder Cancer Stage 0NCT04885309
Efficacy and Safety of Obturator Nerve Block During Transurethral Resection on Non-muscle Invasive Intermediate and High Risk Lateral Wall Bladder Tumours
A study testing Nerve Stimulator-guided Obturator Nerve Block in people with Bladder Cancer Stage 0 and Bladder Cancer Stage I, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
In this prospective randomized controlled study, the effects of obturator nerve block (ONB) on obturator reflex, incomplete resection, perforation, tumor recurrence and progression, presence of muscle tissue in the specimen, need for second transurethral resection of bladder tumours (TURBT) and postoperative… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bladder Cancer Stage 0, Bladder Cancer Stage I
- What is being tested?
- Nerve Stimulator-guided Obturator Nerve Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Apr 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Lateral wall intermediate and high risk non-muscle invasive bladder cancer
Who cannot join
- Low risk non-muscle invasive bladder cancer
- Contraindications for spinal anesthesia
- History of allergy to local anesthetic agents
- Coagulopathy
- Neuromuscular diseases affecting the central nervous system
- Obturator nerve injury
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Training and Research Hospital
Ankara, Altindag, 06230
About this study
Official title: Efficacy and Safety of Obturator Nerve Block During Transurethral Resection on Non-muscle Invasive Intermediate and High Risk Lateral Wall Bladder Tumours Comparing Nerve Stimulator-guided Obturator Nerve Block With Spinal Anaesthesia and Spinal Anaesthesia: A Prospective Randomized Controlled Study
In this prospective randomized controlled study, the effects of obturator nerve block (ONB) on obturator reflex, incomplete resection, perforation, tumor recurrence and progression, presence of muscle tissue in the specimen, need for second transurethral resection of bladder tumours (TURBT) and postoperative complications were investigated in patients who underwent TURBT for intermediate and high risk lateral wall non-muscle invasive bladder tumours (NMIBC).
Read the detailed description
Bladder cancer is among the ten most common types of cancer in the world, with about 550,000 new cases per year. According to GLOBOCAN (Global Cancer Incidence, Mortality and Prevalence) data, bladder cancer accounts for 3% of cancer diagnoses worldwide. It is more common, especially in developed countries. A total of 90% of bladder cancer diagnoses are made in people 55 years of age or older, and the disease is four times more common in men than in women. NMIBC are divided into four groups as low-medium-high and very high risk according to EORTC (European Organization for Research and Treatment of Cancer). Early recurrence was reported as 15%, late recurrence as 25% and progression as 9% with BCG treatment in medium and high risk NMIBC. TURBT is the basic approach in diagnosis and treatment.
The obturator nerve passes through the obturator foramen of the pubis and innervates the adductor muscles of the thigh. It lies within the pelvic cavity close to the prostatic urethra, bladder neck and inferolateral bladder wall. In TURBT, when the bladder is filled with irrigation fluid, the obturator nerve is very close to the bladder sidewall. While performing TURBT of lateral wall bladder tumors, neighboring obturator nerve stimulation may occur during surgical resection, resulting in adductor contraction and leg jerking. This condition, called the obturator reflex, occurs between 55.3% and 100% of lateral bladder tumors.
Serious complications can occur in TURBT, one of which is bladder perforation that may require laparotomy and open repair. Perforation is also associated with poor patient outcomes due to the spread of the tumor into the abdominal cavity and the inability to apply single immediate instillation of intravesical chemotherapy. One of the most important factors affecting the success of TURBT is the presence of residual tumor as a result of incomplete resection. Incomplete resection is associated with both general recurrence and particularly local recurrence, as well as shortening disease-free survival. One of the most important indicators of complete resection is the presence of the detrusor muscle in the TURBT specimen. However, in 10% of all cases, it has been reported that there is no detrusor muscle tissue in the TURBT specimen. Various methods such as administration of muscle relaxants under general anesthesia, less filling of the bladder, reduction of electric current, using a 90-degree classical loop, using bipolar plasmakinetic energy and performing tumor resection with small pieces have been proposed in order to prevent the failure and complications due to obturator reflex that may occur in TURBT.
In combination with spinal anesthesia, ONB is one of the most effective methods used to inhibit the obturator reflex. The importance of spinal anesthesia has increased especially due to the COVID-19 outbreak. Surgery under local / regional anesthesia is recommended as much as possible, especially during the pandemic process, compared to general anesthesia. In this way, it is aimed to reduce the risk of aerosol generating procedures and subsequent viral transmission. ONB has gained more importance in recent years as a result of being performed together with spinal anesthesia.
- Conditions
- Bladder Cancer Stage 0, Bladder Cancer Stage I
- Being tested
- Nerve Stimulator-guided Obturator Nerve Block
- Keywords
- Non-muscle invasive bladder cancer, Obturator nerve block, Transurethral resection
- Medical subject headings
- Urinary Bladder Neoplasms, Non-Muscle Invasive Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nerve Stimulator-guided Obturator Nerve BlockProcedure or surgery
Following the confirmation of spinal anesthesia level in the patients in the ONB group while in the lithotomy position, ONB was applied unilaterally or bilaterally, depending on the tumor position. A needle with a nerve stimulator was advanced vertically 2 cm below and 2 cm from the pubic tubercle. The needle is inserted through the skin and into the lower ramus of the pubic bone. When contraction was observed in the adductor muscle groups and the aspiration was negative, 10 mL 0.25% levobupivacaine at 0.3-0.5 mA was administered. The operation was started 10 minutes after the injection. TURBT operations were performed with a 30 degree optic and a 26 F bipolar resectoscope. All spinal anesthesia and ONB procedures were performed by the same anesthesia team. All TURBT operations were performed by the same surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Obturator Nerve Block + Spinal Anaesthesia | Active comparator | Patients who underwent obturator nerve block with spinal anesthesia prior to TURBT Receives: Procedure: Nerve Stimulator-guided Obturator Nerve Block |
| Spinal Anaesthesia | Sham comparator | Patients who underwent spinal anesthesia prior to TURBT Receives: Procedure: Nerve Stimulator-guided Obturator Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Obturator Reflex
Rate of patients who had an obturator reflex during the operation
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Jan 2018
- Primary completion1 Apr 2019
- Study completion1 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder Cancer Stage 0Studies 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
- Participant
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Kaan Yıldız, Ankara Training and Research Hospital
- Investigators
- Ali Kaan Yildiz, Principal investigator, Ankara Training and Resarch Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04885309
- Sponsor's protocol ID
- ONB2021
- Status last verified
- May 2021
- First submitted
- 10 May 2021
- Last updated
- 13 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Obturator Nerve Block During Transurethral Resection on Non-muscle Invasive Intermediate and High Risk Lateral Wall Bladder Tumours Comparing Nerve Stimulator-guided Obturator Nerve Block With Spinal Anaesthesia and Spinal Anaesthesia: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04885309
- Acronym / sponsor ID
- ONB2021
- Conditions
- Bladder Cancer Stage 0, Bladder Cancer Stage I
- Keywords
- Non-muscle invasive bladder cancer, Obturator nerve block, Transurethral resection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Ankara Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- 1 Apr 2021 (actual)
- First posted
- 13 May 2021 (actual)
- 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.
In this prospective randomized controlled study, the effects of obturator nerve block (ONB) on obturator reflex, incomplete resection, perforation, tumor recurrence and progression, presence of muscle tissue in the specimen, need for second transurethral resection of bladder tumours (TURBT) and postoperative complications were investigated in patients who underwent TURBT for intermediate and high risk lateral wall non-muscle invasive bladder tumours (NMIBC).
Detailed description
Bladder cancer is among the ten most common types of cancer in the world, with about 550,000 new cases per year. According to GLOBOCAN (Global Cancer Incidence, Mortality and Prevalence) data, bladder cancer accounts for 3% of cancer diagnoses worldwide. It is more common, especially in developed countries. A total of 90% of bladder cancer diagnoses are made in people 55 years of age or older, and the disease is four times more common in men than in women. NMIBC are divided into four groups as low-medium-high and very high risk according to EORTC (European Organization for Research and Treatment of Cancer). Early recurrence was reported as 15%, late recurrence as 25% and progression as 9% with BCG treatment in medium and high risk NMIBC. TURBT is the basic approach in diagnosis and treatment.
The obturator nerve passes through the obturator foramen of the pubis and innervates the adductor muscles of the thigh. It lies within the pelvic cavity close to the prostatic urethra, bladder neck and inferolateral bladder wall. In TURBT, when the bladder is filled with irrigation fluid, the obturator nerve is very close to the bladder sidewall. While performing TURBT of lateral wall bladder tumors, neighboring obturator nerve stimulation may occur during surgical resection, resulting in adductor contraction and leg jerking. This condition, called the obturator reflex, occurs between 55.3% and 100% of lateral bladder tumors.
Serious complications can occur in TURBT, one of which is bladder perforation that may require laparotomy and open repair. Perforation is also associated with poor patient outcomes due to the spread of the tumor into the abdominal cavity and the inability to apply single immediate instillation of intravesical chemotherapy. One of the most important factors affecting the success of TURBT is the presence of residual tumor as a result of incomplete resection. Incomplete resection is associated with both general recurrence and particularly local recurrence, as well as shortening disease-free survival. One of the most important indicators of complete resection is the presence of the detrusor muscle in the TURBT specimen. However, in 10% of all cases, it has been reported that there is no detrusor muscle tissue in the TURBT specimen. Various methods such as administration of muscle relaxants under general anesthesia, less filling of the bladder, reduction of electric current, using a 90-degree classical loop, using bipolar plasmakinetic energy and performing tumor resection with small pieces have been proposed in order to prevent the failure and complications due to obturator reflex that may occur in TURBT.
In combination with spinal anesthesia, ONB is one of the most effective methods used to inhibit the obturator reflex. The importance of spinal anesthesia has increased especially due to the COVID-19 outbreak. Surgery under local / regional anesthesia is recommended as much as possible, especially during the pandemic process, compared to general anesthesia. In this way, it is aimed to reduce the risk of aerosol generating procedures and subsequent viral transmission. ONB has gained more importance in recent years as a result of being performed together with spinal anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obturator Nerve Block + Spinal Anaesthesia | Active comparator | Procedure: Nerve Stimulator-guided Obturator Nerve BlockPatients who underwent obturator nerve block with spinal anesthesia prior to TURBT |
| Spinal Anaesthesia | Sham comparator | Procedure: Nerve Stimulator-guided Obturator Nerve BlockPatients who underwent spinal anesthesia prior to TURBT |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Lateral wall intermediate and high risk non-muscle invasive bladder cancer
Key exclusion criteria (6 listed)
- Low risk non-muscle invasive bladder cancer
- Contraindications for spinal anesthesia
- History of allergy to local anesthetic agents
- Coagulopathy
- Neuromuscular diseases affecting the central nervous system
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-guided Obturator Nerve BlockFollowing the confirmation of spinal anesthesia level in the patients in the ONB group while in the lithotomy position, ONB was applied unilaterally or bilaterally, depending on the tumor position. A needle with a nerve stimulator was advanced vertically 2 cm below and 2 cm from the pubic tubercle. The needle is inserted through the skin and into the lower ramus of the pubic bone. When contraction was observed in the adductor muscle groups and the aspiration was negative, 10 mL 0.25% levobupivacaine at 0.3-0.5 mA was administered. The operation was started 10 minutes after the injection. TURBT operations were performed with a 30 degree optic and a 26 F bipolar resectoscope. All spinal anesthesia and ONB procedures were performed by the same anesthesia team. All TURBT operations were performed by the same surgeon. | Procedure or surgery | Obturator Nerve Block + Spinal Anaesthesia, Spinal Anaesthesia |
Primary outcome
Rate of Obturator Reflex
Time frame: One year
Rate of patients who had an obturator reflex during the operation
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 13 May 2021.
- 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.
Ali Kaan Yildiz principal investigator
Ankara Training and Resarch Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nerve Stimulator-guided Obturator Nerve Block in people with Bladder Cancer Stage 0 and Bladder Cancer Stage I, run by Ankara Training and Research Hospital at 1 site in Turkey (Türkiye).
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 6 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 13 May 2021. 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. 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?
Rate of Obturator Reflex (time frame: One year). 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 13 May 2021.