NCT02696733

Brief Summary

Obturator nerve block is an effective method to prevent adductor muscles contraction during transurethral resection of bladder tumour localized on the lateral wall. Due to prior spinal anaesthesia the patient does not feel uncomfortable during the blockade and the interadductor approach gives the possibility to perform it in the lithotomy position. The aim of the study was to evaluate the safety and effectiveness of ultrasound-guided obturator nerve identification and blockade for TURBT.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

1.8 years

First QC Date

February 22, 2016

Last Update Submit

July 13, 2017

Conditions

Urinary Bladder NeoplasmsTransurethral ResectionNerve Block

Keywords

TURBTultrasound guidedONBinteradductor approach

Outcome Measures

Primary Outcomes (1)

  • Effectiveness of ultrasound guided obturator nerve block - evaluated by a number of participants having transurethral resection of bladder tumor without unintended obturator nerve stimulation.

    The investigator evaluates whether the urologist was able to perform safe electroresection of bladder tumor with no extremity movement. All extremity movements due to obturator nerve stimulation and all necessities to perform general anesthesia will be counted as unsuccessful ultrasound - guided ONB.

    30 months

Secondary Outcomes (3)

  • Success rate of obturator nerve visualization with ultrasounds

    30 months

  • Efficacy of ONB - measured with nerve stimulator built in the resectoscope

    30 months

  • Safety of ultrasound-guided ONB measured by number of complications

    30 months

Study Arms (1)

UG - ONB

EXPERIMENTAL

Patients with the bladder tumor located on the lateral wall, with the high risk of adductor muscles contraction during TURBT under spinal anesthesia.

Device: UltrasoundDrug: lidocaine 2%Drug: 0.9% Natrium Chloratum with a 2nd generation cephalosporin

Interventions

UltrasoundDEVICE

Ultrasound-guided obturator nerve localization

Also known as: USG
UG - ONB
lidocaine 2%DRUG

local anesthetic used to block the obturator nerve

UG - ONB
0.9% Natrium Chloratum with a 2nd generation cephalosporinDRUG
UG - ONB

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • informed consent
  • bladder tumor located on the lateral wall
  • transurethral resection of the bladder tumor
  • urologist decision that there is a risk of the stimulation of obturator nerve during resection
  • spinal anesthesia

You may not qualify if:

  • patients' refusal
  • contraindications for spinal anesthesia
  • skin lesions at injection site
  • patients who really did not need ONB.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

I Department od Anaesthesiology and Intensive Care

Warsaw, 02-005, Poland

RECRUITING

I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw

Warsaw, 02-005, Poland

RECRUITING

Related Publications (2)

  • Pladzyk K, Jureczko L, Lazowski T. Over 500 obturator nerve blocks in the lithotomy position during transurethral resection of bladder tumor. Cent European J Urol. 2012;65(2):67-70. doi: 10.5173/ceju.2012.02.art2. Epub 2012 Jun 12.

    PMID: 24578931BACKGROUND

  • Thallaj A, Rabah D. Efficacy of ultrasound-guided obturator nerve block in transurethral surgery. Saudi J Anaesth. 2011 Jan;5(1):42-4. doi: 10.4103/1658-354X.76507.

    PMID: 21655015RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Karolina Dobronska, MD

    I Department of Anaesthesiology and Intensive Care

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolina Dobronska, MD

CONTACT

+48 22 502 17 27karolinapladzyk@gmail.com

Lidia I Jureczko, PhD MD

CONTACT

+48 22 502 17 27jureczko@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 2, 2016

Study Start

February 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 18, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

PL(2)