Trials Sponsors Conditions Drugs Pricing

Conditions

Bladder Cancer Stage 0 Bladder Cancer Stage I

Keywords

Non-muscle invasive bladder cancerObturator nerve blockTransurethral resection

Outcome Measures

Primary Outcomes (1)

Rate of Obturator Reflex
Rate of patients who had an obturator reflex during the operation
One year

Study Arms (2)

Obturator Nerve Block + Spinal Anaesthesia

ACTIVE COMPARATOR

Patients who underwent obturator nerve block with spinal anesthesia prior to TURBT

Procedure: Nerve Stimulator-guided Obturator Nerve Block

Spinal Anaesthesia

SHAM COMPARATOR

Patients who underwent spinal anesthesia prior to TURBT

Procedure: Nerve Stimulator-guided Obturator Nerve Block

Interventions

Nerve Stimulator-guided Obturator Nerve BlockProcedure

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.

Obturator Nerve Block + Spinal AnaesthesiaSpinal Anaesthesia

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 90 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Lateral wall intermediate and high risk non-muscle invasive bladder cancer

You may not qualify if:

Sponsors & Collaborators

Ankara Training and Research Hospital
Otherlead

Study Sites (1)

Ankara Training and Research Hospital

Ankara, Altindag, 06230, Turkey (Türkiye)

MeSH Terms

Conditions

Urinary Bladder NeoplasmsNon-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital DiseasesCarcinomaNeoplasms, Glandular and Epithelial

Study Officials

Ali Kaan Yildiz
Ankara Training and Resarch Hospital
PRINCIPAL INVESTIGATOR

Enrollment

104 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

May 10, 2021

First Posted

May 13, 2021

Study Start

January 1, 2018

Actual (reported)

Efficacy and Safety of Obturator Nerve Block During Transurethral Resection on Non-muscle Invasive Intermediate and High Risk Lateral Wall Bladder Tumours

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Obturator Nerve Block + Spinal Anaesthesia

Spinal Anaesthesia

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Obturator Nerve Block + Spinal Anaesthesia

Spinal Anaesthesia

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations