- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04885309
Efficacy and Safety of Obturator Nerve Block During Transurethral Resection on Non-muscle Invasive Intermediate and High Risk Lateral Wall Bladder Tumours
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Altindag
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Ankara, Altindag, Turkey, 06230
- Ankara Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Lateral wall intermediate and high risk non-muscle invasive bladder cancer
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Obturator Nerve Block + Spinal Anaesthesia
Patients who underwent obturator nerve block with spinal anesthesia prior to TURBT
|
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.
|
Sham Comparator: Spinal Anaesthesia
Patients who underwent spinal anesthesia prior to TURBT
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of Obturator Reflex
Time Frame: One year
|
Rate of patients who had an obturator reflex during the operation
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One year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ONB2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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