- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07481123
COMPARISON OF OBTURATOR NERVE BLOCK TECHNIQUES IN TURBT
COMPARISON OF THE EFFECT OF SUBPECTINEAL OBTURATOR NERVE BLOCK AND INTERFASCIAL OBTURATOR NERVE BLOCK ON ADDUKTOR MUSCLE SPASM IN PATIENTS WHO UNDERWENT TUR-BT OPERATION
Bladder cancer is one of the most common cancers in older adults. The standard treatment for many bladder tumors is a surgical procedure called transurethral resection of bladder tumor (TUR-BT). During this operation, tumors located on the side wall of the bladder may trigger an involuntary leg movement known as the "obturator reflex." This reflex occurs when electrical stimulation during surgery activates the obturator nerve, causing sudden contraction of the inner thigh (adductor) muscles. Such muscle spasms can lead to serious complications, including incomplete tumor removal or bladder perforation.
To prevent this reflex, anesthesiologists perform an obturator nerve block (ONB), a procedure in which local anesthetic medication is injected around the nerve to temporarily stop its function. With advances in ultrasound technology, different ultrasound-guided techniques have been developed to perform this nerve block more safely and effectively.
There are two commonly used approaches. The first is the interfacial (distal) technique, in which two separate injections are performed to block the anterior and posterior branches of the obturator nerve. The second is the subpectineal (proximal) technique, in which the nerve is blocked with a single injection at a more proximal location, potentially using a smaller amount of local anesthetic.
The purpose of this study was to compare these two ultrasound-guided techniques in patients undergoing TUR-BT surgery. The aim of this study was to compare the effectiveness and safety of the subpectineal and interfacial obturator nerve block techniques in preventing adductor muscle spasm during surgery.
Sixty patients aged between 50 and 80 years who were scheduled for TUR-BT were randomly assigned to receive either the subpectineal or the interfacial obturator nerve block. The main outcome measured was the occurrence and severity of adductor muscle spasm during surgery. Secondary outcomes included the number of needle insertions, duration of anesthesia and surgery, and any complications related to the block.
The hypothesis of this study was that the subpectineal technique would provide comparable effectiveness in preventing adductor muscle spasm compared with the interfacial technique while requiring fewer injections and a lower volume of local anesthetic.
The results of this study may help determine the most effective and practical technique for preventing surgical complications during bladder tumor surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Transurethral resection of bladder tumor (TUR-BT) is the standard diagnostic and therapeutic procedure for non-muscle invasive bladder cancer. During resection of tumors located on the lateral bladder wall, electrical stimulation may activate the obturator nerve, resulting in sudden contraction of the adductor muscles of the thigh. This phenomenon, known as the obturator reflex, may cause incomplete tumor resection, bladder perforation, bleeding, or tumor cell dissemination.
Obturator nerve block (ONB) has been shown to significantly reduce the incidence and severity of adductor muscle spasm during TUR-BT. With the increasing use of ultrasound guidance, several proximal and distal approaches have been described to improve block success and safety profile.
The distal (interfacial) technique requires separate blockade of the anterior and posterior branches of the obturator nerve between the adductor muscle groups. This approach typically involves two injections and a higher total volume of local anesthetic. In contrast, the proximal (subpectineal) technique targets the obturator nerve before its division, allowing a single-injection block performed in the fascial plane between the pectineus and obturator externus muscles.
This prospective, randomized clinical study was conducted to compare the effectiveness of ultrasound-guided subpectineal and interfacial obturator nerve block techniques in patients undergoing TUR-BT. Patients were allocated into two groups using a computer-generated randomization method. All nerve blocks were performed under real-time ultrasound guidance by experienced anesthesiologists.
In the subpectineal approach, a single injection of 10 mL of 0.375% bupivacaine was administered into the fascial plane between the pectineus and obturator externus muscles. In the interfacial approach, 10 mL of 0.375% bupivacaine was injected between the adductor longus and brevis muscles to block the anterior branch, and an additional 10 mL was injected between the adductor brevis and magnus muscles to block the posterior branch.
The study was designed to evaluate whether the proximal subpectineal approach provides comparable prevention of adductor muscle contraction while potentially simplifying the procedure by reducing the number of injections and local anesthetic volume. Safety parameters and perioperative characteristics were also assessed.
Statistical analyses were performed using appropriate comparative tests according to data distribution. A p-value < 0.05 was considered statistically significant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ankara
-
Ankara, Ankara, Turkey (Türkiye)
- Ankara Etlik City Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged between 50 and 80 years
- Diagnosed with bladder tumor and scheduled for transurethral resection of bladder tumor (TURBT)
- Classified as American Society of Anesthesiologists (ASA) physical status I-III
- Provided written informed consent
Exclusion Criteria:
- Coagulopathy or anticoagulant therapy contraindicating regional anesthesia
- Known allergy to local anesthetics
- Infection at the injection site
- Pre-existing neuromuscular disorder affecting lower extremities
- Severe cardiac, hepatic, or renal dysfunction
- Inability to provide informed consent
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: Subpectineal Obturator Nerve Block
Participants in this arm received an ultrasound-guided subpectineal obturator nerve block prior to transurethral resection of bladder tumor.
A single injection of 10 mL of 0.375% bupivacaine was administered into the fascial plane between the pectineus and obturator externus muscles to achieve proximal blockade of the obturator nerve.
|
Ultrasound-guided single-injection obturator nerve block performed between the pectineus and obturator externus muscles using 10 mL of 0.375% bupivacaine.
|
|
Active Comparator: Interfacial Obturator Nerve Block
Participants in this arm received an ultrasound-guided interfacial obturator nerve block prior to transurethral resection of bladder tumor.
Two separate injections of 10 mL of 0.375% bupivacaine were administered between the adductor longus and brevis muscles and between the adductor brevis and magnus muscles to block the anterior and posterior branches of the obturator nerve.
|
Ultrasound-guided obturator nerve block performed with two separate injections between adductor muscle groups using 0.375% bupivacaine.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence and Severity of Intraoperative Adductor Muscle Spasm
Time Frame: During surgery (intraoperative period)
|
Adductor muscle spasm was evaluated intraoperatively and graded using a four-level scale (Grade I-IV), with higher grades indicating stronger contraction and possible interference with the surgical procedure.
|
During surgery (intraoperative period)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Needle Insertions
Time Frame: During the block procedure (preoperative period)
|
The number of needle insertions/attempts required to complete the ultrasound-guided obturator nerve block was recorded for each participant.
|
During the block procedure (preoperative period)
|
|
Block-Related Complications
Time Frame: From block procedure through end of surgery (perioperative period)
|
The occurrence of complications potentially related to the obturator nerve block (e.g., vascular puncture, hematoma, bladder perforation) was recorded.
|
From block procedure through end of surgery (perioperative period)
|
Collaborators and Investigators
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- code 141/09 date 04.07.2022
- 141/09-04/07/2022 (Other Identifier: Committee of Health Sciences University Dışkapı Yıldırım Beyazıt Training and Research Hospital Ethics Committee)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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.
Clinical Trials on Bladder Cancer
-
University of Southern CaliforniaNational Cancer Institute (NCI)TerminatedStage III Bladder Cancer | No Evidence of Disease | Stage II Bladder Cancer | Stage IVA Bladder Cancer | Stage IVB Bladder CancerUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteCompletedMuscle-Invasive Bladder Carcinoma | Bladder Cancer Stage II | Bladder Cancer Stage III | Bladder Cancer Stage IVUnited States
-
Fox Chase Cancer CenterTerminatedStage III Bladder Cancer | Distal Urethral Cancer | Proximal Urethral Cancer | Squamous Cell Carcinoma of the Bladder | Urethral Cancer Associated With Invasive Bladder Cancer | Stage II Bladder CancerUnited States
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnRecurrent Bladder Cancer | Urinary Complications | Stage 0 Bladder Cancer | Stage I Bladder Cancer | Stage II Bladder Cancer
-
Academisch Medisch Centrum - Universiteit van Amsterdam...Bristol-Myers SquibbRecruitingUrinary Bladder Cancer | Invasive Bladder CancerNetherlands
-
National Cancer Institute (NCI)CompletedStage III Bladder Cancer | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
-
National Cancer Institute (NCI)TerminatedStage III Bladder Cancer | Stage IV Bladder Cancer | Recurrent Bladder Carcinoma | Bladder Adenocarcinoma | Bladder Squamous Cell Carcinoma | Bladder Urothelial Carcinoma | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Bladder Cancer | Stage III Bladder Cancer | Stage IV Bladder Cancer | Transitional Cell Carcinoma of the Bladder | Stage I Bladder Cancer | Stage II Bladder CancerUnited States
-
University of WashingtonNational Cancer Institute (NCI)CompletedStage III Bladder Cancer | Stage IV Bladder Cancer | Recurrent Bladder Carcinoma | Stage II Bladder CancerUnited States
-
Baylor College of MedicinePfizerTerminatedBladder Cancer | Invasive Bladder Cancer | Metastatic Bladder CancerUnited States
Clinical Trials on Subpectineal Obturator Nerve Block
-
Yonsei UniversityCompleted
-
Milton S. Hershey Medical CenterCompleted
-
CMC Ambroise ParéNot yet recruitingTotal Knee ArthroplastyFrance
-
Campus Bio-Medico UniversityCompletedPain, Postoperative | Hip Fractures | Coagulopathy | Comorbidities and Coexisting ConditionsItaly
-
Konya Meram State HospitalRecruitingPostoperative Pain | Osteoarthritis of the Hip | Quality of RecoveryTurkey (Türkiye)
-
Lawson Health Research InstituteCompletedAnterior Cruciate Ligament ReconstructionCanada
-
Nanjing First Hospital, Nanjing Medical UniversityActive, not recruiting
-
Clinique Medipole GaronneCompletedPrimary Total Knee ArthroplastyFrance
-
Ankara Training and Research HospitalCompletedBladder Cancer Stage 0 | Bladder Cancer Stage ITurkey
-
Ankara City Hospital BilkentNot yet recruitingObturator Nerve Block | Ultrasound Guided Nerve Block | Complications NeurologicalTurkey