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NCT05540847 Clinical Trial

Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block

Bladder Neoplasm Clinical Trial

Official title:
Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05540847
Other study ID # 141/09
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 16, 2022
Est. completion date April 23, 2023

Study information
Verified date April 2023
Source Diskapi Teaching and Research Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aimed to assess the effectiveness of the ultrasound-guided interfascial injection approach with the subpectineal injection technique for obturator nerve block in bladder cancers undergoing transurethral resection of bladder tumor (TURBT) under spinal anesthesia.

Recruitment information / eligibility
Status Completed
Enrollment 60
Est. completion date April 23, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Lateral wall bladder tumour - ASA I-II patients Exclusion Criteria: - Contraindications for spinal anesthesia, - Tumors that disrupt the integrity of the bladder, - Coagulation disorders, - Uncooperative patients, - Allergy to local anesthetics.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Interfascial Injection
Interfascial Injection on Ultrasound-guided Obturator Nerve Block
• Subpectineal Injection
Subpectineal Injection on Ultrasound-guided Obturator Nerve Block

Locations
Country Name City State
Turkey Health Science University Diskapi Yildirim Beyazit Training and Research Hospital Yenimahalle Ankara

Sponsors (1)
Lead Sponsor Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Success rate of obturatr nerve block The success or fail of the obturator nerve block will be conformed using nerve stimulator. Detecting muscles twitch will br considered to be a fail. Peroperative period
Secondary Number of adductor muscle spazms Number of adductor muscle spazms in each group will be noted during the intraoperative period. Intraoperative period
Secondary Sensory block Sensory block area will be evaluated by a pin prick at in the dermatomal areas related obturator nerve and branches. 30 minutes after the intervention
Secondary Patient satisfaction Changes in overall satisfaction will be assessed using a 5 point Likert Scale ( 1-very dissatisfied, 2- dissatisfied, 3- neutral, 4-satisfied, 5 - very satisfied Peroperative period
Secondary Procedure time Block performance time will be recorded from the time the first ultrasound image is obtained until the procedure is completed During the procedure
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Terminated NCT03335059 - Mitomycin C Intravesical Chemotherapy in Conjunction With Synergo® Radiofrequency-Induced Hyperthermia for Treatment of Carcinoma in Situ Non-Muscle Invasive Bladder Cancer Patients Unresponsive to Bacillus Calmette-Guérin, With or Without Papillary Tumors. Phase 3
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