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Ultrasound-Guided ONB for Transurethral Procedures - Interadductor Approach

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02696733
Recruitment Status : Unknown
Verified July 2017 by Karolina Dobrońska, Medical University of Warsaw.
Recruitment status was:  Recruiting
First Posted : March 2, 2016
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Karolina Dobrońska, Medical University of Warsaw

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.

Condition or disease Intervention/treatment Phase
Urinary Bladder Neoplasms Transurethral Resection Nerve Block Device: Ultrasound Drug: lidocaine 2% Drug: 0.9% Natrium Chloratum with a 2nd generation cephalosporin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ultrasound-Guided Obturator Nerve Block for Transurethral Procedures - Interadductor Approach
Study Start Date : February 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: UG - ONB
Patients with the bladder tumor located on the lateral wall, with the high risk of adductor muscles contraction during TURBT under spinal anesthesia.
Device: Ultrasound
Ultrasound-guided obturator nerve localization
Other Name: USG

Drug: lidocaine 2%
local anesthetic used to block the obturator nerve

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



Primary Outcome Measures :
  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. [ Time Frame: 30 months ]
    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.


Secondary Outcome Measures :
  1. Success rate of obturator nerve visualization with ultrasounds [ Time Frame: 30 months ]
    The investigators evaluate whether it was possible to visualize the obturator nerve in the fascial plane

  2. Efficacy of ONB - measured with nerve stimulator built in the resectoscope [ Time Frame: 30 months ]
    A nerve stimulator (Neurotester FB2, ERBE) is used to evaluate the efficacy of the nerve block. Current flow settings are progressively marked relative to a 1-5 scale .

  3. Safety of ultrasound-guided ONB measured by number of complications [ Time Frame: 30 months ]
    hematoma , lidocaine overdose symptoms, bladder perforation,obturator nerve injury



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696733


Contacts
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Contact: Karolina Dobronska, MD +48 22 502 17 27 karolinapladzyk@gmail.com
Contact: Lidia I Jureczko, PhD MD +48 22 502 17 27 jureczko@gmail.com

Locations
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Poland
I Department od Anaesthesiology and Intensive Care Recruiting
Warsaw, Poland, 02-005
Contact: Karolina Dobronska, MD    +48 22 501 17 27    karolinapladzyk@gmail.com   
Contact: Lidia I Jureczko, PhD MD    +48 22 501 17 27    jureczko@gmail.com   
Principal Investigator: Karolina Dobronska, MD         
Sub-Investigator: Lidia I Jureczko, PhD MD         
I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw Recruiting
Warsaw, Poland, 02-005
Contact: Karolina Dobronska, MD    +48 22 501 17 27    karolinapladzyk@gmail.com   
Contact: Lidia I Jureczko, PhD MD    +48 22 501 17 27    jureczko@gmail.com   
Principal Investigator: Karolina Dobronska, MD         
Sub-Investigator: Lidia I Jureczko, PhD MD         
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Principal Investigator: Karolina Dobronska, MD I Department of Anaesthesiology and Intensive Care

Publications of Results:
Other Publications:
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Responsible Party: Karolina Dobrońska, M.D., Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02696733    
Other Study ID Numbers: U/1/2014
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Karolina Dobrońska, Medical University of Warsaw:
TURBT
ultrasound guided
ONB
interadductor approach
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Cephalosporins
Anti-Bacterial Agents
Anti-Infective Agents