search
Back to results

Ultrasound-Guided ONB for Transurethral Procedures - Interadductor Approach

Primary Purpose

Urinary Bladder Neoplasms, Transurethral Resection, Nerve Block

Status
Unknown status
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Ultrasound
lidocaine 2%
0.9% Natrium Chloratum with a 2nd generation cephalosporin
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Bladder Neoplasms focused on measuring TURBT, ultrasound guided, ONB, interadductor approach

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • I Department od Anaesthesiology and Intensive CareRecruiting
  • I Department of Anaesthesiology and Intensive Care, Medical University of WarsawRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

UG - ONB

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Success rate of obturator nerve visualization with ultrasounds
The investigators evaluate whether it was possible to visualize the obturator nerve in the fascial plane
Efficacy of ONB - measured with nerve stimulator built in the resectoscope
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 .
Safety of ultrasound-guided ONB measured by number of complications
hematoma , lidocaine overdose symptoms, bladder perforation,obturator nerve injury

Full Information

First Posted
February 22, 2016
Last Updated
July 13, 2017
Sponsor
Medical University of Warsaw
search

1. Study Identification

Unique Protocol Identification Number
NCT02696733
Brief Title
Ultrasound-Guided ONB for Transurethral Procedures - Interadductor Approach
Official Title
Ultrasound-Guided Obturator Nerve Block for Transurethral Procedures - Interadductor Approach
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The basic methods for diagnosis and management of bladder cancer are endoscopic procedures. Transurethral resection of bladder tumor (TURBT) is usually performed under spinal anesthesia that does not prevent an unintended stimulation of the obturator nerve (ON) when electroresection is performed on the lateral wall of the bladder. This sensorimotor nerve arises from the lumbar plexus at L2-L4. It innervates the muscles responsible for adducting the thigh and the skin on the surface of the paramedian segment of the thigh. During TURBT, when the bladder has been filled with irrigation fluid, the ON is directly adjacent to the lateral wall of the bladder and it can be stimulated during the electroresection. Sudden contraction of the adductor muscles of the thigh, may lead to perforation of bladder wall with the resectoscope loop. In the Department of General, Oncologic and Functional Urology, Medical University of Warsaw approximately 500 TURBT are performed every year; 7% of them necessitate the prevention of ON stimulation. Anesthetists perform obturator nerve block (ONB) - the anterior branch, using the stimulator for the identification with the 94% efficacy. Recently, ultrasound guidance has been used to enhance the safety and efficacy of the nerve blocks that is why we have decided to evaluate the effectiveness of ONB performed with ultrasounds. An approval from the Medical University of Warsaw Bioethical Committee has been obtained. Patients need to give written informed consent to participate in the study. It is anticipated that 100 patients with TURBT performed under spinal anesthesia that, after the urologist decision, necessitate the ONB will be enrolled in this study. Before the procedure an oral premedication is given. After admission to the operating room, intravenous access is established and the patient receives a drip infusion of 500 ml 0.9% Natrium Chloratum with an antibiotic (2nd generation cephalosporin). Constant monitoring is ensured of ECG, heart rate, and pulse oxymetry. Non-invasive blood pressure measurement is taken every five minutes. To maintain patients' blood oxygenation, oxygen is delivered with the use of a facemask. Spinal anesthesia is performed with patients in the sitting position, most frequently in the L3 L4 space (in the case of technical difficulties - L2 L3 or L4 L5) using 8-15 mg 0.5% hyperbaric bupivacaine depending on the patient's anthropometric parameters. The needles used are 25-27G pencil point. After drug administration, the patient is placed in the supine position. Upon reaching the appropriate anesthesia level (Th10), which blocks conduction in the sensory nerve fibers of the bladder, the patient is placed in the lithotomy position. In the case of tumors located on the lateral wall of the bladder, the safety of TURBT is ensured using a neurotest performed by an urologist with a nerve stimulator built into the resectoscope (Neurotester FB2, ERBE). The extremity movement leads to the decision to block the ON. Ultrasound-guided ONB procedure: The patient remains in the lithotomy position. For nerve identification a linear transducer is used. It is placed next to the grain to visualize three adductor muscles. Between adductor longus and adductor brevis, in fascial plane, an anterior branch of obturator should be visualized. The needle is advanced toward the nerve in an out-of-plane trajectory. The local anesthetic is injected after heme-negative aspiration. The resistance during injection is avoided to reduce the risk of intraneural injection. If there are problems with nerve identification the anesthetic is injected in fascial plane between adductors muscles - longus and brevis. 10 ml of 2% lidocaine is used for single block and 2 x 10 ml of 2% lidocaine with epinephrine when bilateral one is needed. Before TURBT starts again, the urologist once more perform the neurotest to evaluate the ONB efficacy. After enrolling 50 patients to the study the results will be evaluated and the decision whether to decrease the amount of 10 ml of 2% lidocaine for injection will be taken.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Bladder Neoplasms, Transurethral Resection, Nerve Block
Keywords
TURBT, ultrasound guided, ONB, interadductor approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UG - ONB
Arm Type
Experimental
Arm Description
Patients with the bladder tumor located on the lateral wall, with the high risk of adductor muscles contraction during TURBT under spinal anesthesia.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Other Intervention Name(s)
USG
Intervention Description
Ultrasound-guided obturator nerve localization
Intervention Type
Drug
Intervention Name(s)
lidocaine 2%
Intervention Description
local anesthetic used to block the obturator nerve
Intervention Type
Drug
Intervention Name(s)
0.9% Natrium Chloratum with a 2nd generation cephalosporin
Primary Outcome Measure Information:
Title
Effectiveness of ultrasound guided obturator nerve block - evaluated by a number of participants having transurethral resection of bladder tumor without unintended obturator nerve stimulation.
Description
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.
Time Frame
30 months
Secondary Outcome Measure Information:
Title
Success rate of obturator nerve visualization with ultrasounds
Description
The investigators evaluate whether it was possible to visualize the obturator nerve in the fascial plane
Time Frame
30 months
Title
Efficacy of ONB - measured with nerve stimulator built in the resectoscope
Description
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 .
Time Frame
30 months
Title
Safety of ultrasound-guided ONB measured by number of complications
Description
hematoma , lidocaine overdose symptoms, bladder perforation,obturator nerve injury
Time Frame
30 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karolina Dobronska, MD
Phone
+48 22 502 17 27
Email
karolinapladzyk@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lidia I Jureczko, PhD MD
Phone
+48 22 502 17 27
Email
jureczko@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karolina Dobronska, MD
Organizational Affiliation
I Department of Anaesthesiology and Intensive Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
I Department od Anaesthesiology and Intensive Care
City
Warsaw
ZIP/Postal Code
02-005
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karolina Dobronska, MD
Phone
+48 22 501 17 27
Email
karolinapladzyk@gmail.com
First Name & Middle Initial & Last Name & Degree
Lidia I Jureczko, PhD MD
Phone
+48 22 501 17 27
Email
jureczko@gmail.com
First Name & Middle Initial & Last Name & Degree
Karolina Dobronska, MD
First Name & Middle Initial & Last Name & Degree
Lidia I Jureczko, PhD MD
Facility Name
I Department of Anaesthesiology and Intensive Care, Medical University of Warsaw
City
Warsaw
ZIP/Postal Code
02-005
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karolina Dobronska, MD
Phone
+48 22 501 17 27
Email
karolinapladzyk@gmail.com
First Name & Middle Initial & Last Name & Degree
Lidia I Jureczko, PhD MD
Phone
+48 22 501 17 27
Email
jureczko@gmail.com
First Name & Middle Initial & Last Name & Degree
Karolina Dobronska, MD
First Name & Middle Initial & Last Name & Degree
Lidia I Jureczko, PhD MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24578931
Citation
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.
Results Reference
background
PubMed Identifier
21655015
Citation
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.
Results Reference
result

Learn more about this trial

Ultrasound-Guided ONB for Transurethral Procedures - Interadductor Approach

We'll reach out to this number within 24 hrs