Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001050347
Ethics application status
Approved
Date submitted
27/05/2017
Date registered
18/07/2017
Date last updated
5/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of nerve blocks applied for preventing muscle contractions in bladder tumor surgeries
Scientific title
Comparison of classic and inguinal obturator nerve blocks applied for preventing adductor muscle contractions in bladder tumor surgeries: A prospective randomized trial
Secondary ID [1] 292064 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bladder tumor 303471 0
adductor muscle contractions 303472 0
Condition category
Condition code
Anaesthesiology 302880 302880 0 0
Other anaesthesiology
Cancer 302881 302881 0 0
Bladder
Surgery 302882 302882 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Before surgery, 500 mL intravenous 0.9% NaCl is administered to the patients. Heart rate, SpO2, blood pressure, and electrocardiography are monitored in the operating room. Spinal anesthesia is performed using 12.5 mg hyperbaric bupivacaine after insertion of a 25-gauge Quincke spinal needle from L3-4 or L4-5 in the sitting position. Patients are laid in the supine position. Development of sensory block is examined at the T10 level.

Required anatomic markings were made on the wall where the tumor was located by the approach to be applied:
In the classic method, the puncture point is marked 1.5 cm lateral of tuberculum pubis and 1.5 cm caudal.
In the inguinal method, the tuberculum pubis, spina iliaca anterior superior, inguinal ligament, and femoral artery are marked. The puncture entry point is determined as the middle of the tuberculum pubis and femoral artery, and 5-8 cm below the inguinal ligament.
Obturator nerve block (ONB) has been performed in surgeries of transurethral resection of bladder tumors (TUR-BT) for the prevention of the development of obturator muscle contraction. Currently, classic and inguinal approaches are frequently being used.

Patients are randomized for classic (n=33) and inguinal (n=33) ONBs. Simple randomization is done before study commencement by the Excel (Microsoft, Redmond, WA, USA) random number generation function. Adductor muscle contractions that occurred during the resection are recorded by a urologist who is blinded to the ONB technique.

The peripheral nerve stimulator (Pajunk, Melsungen, Germany) is adjusted to 1.5 mA 1 Hz. Insertion is applied from the determined points using an isolated 22-gauge, 100-mm nerve stimulator needle (Pajunk, Melsungen, Germany). The needle is directed cephalad in the inguinal approach. In the classic method, the needle is perpendicularly inserted and slightly withdrawn after reaching the bone; the needle is manipulated 2-4 cm towards the medial. First, suction is performed, and then ten mL 0.25% bupivacaine are administered when an adductor muscle contraction area is detected with the peripheral nerve stimulator between the range of 0.4-0.7 mA.
All ONB and TUR-BT procedures are performed by the same anesthesiologists and urologists.
Intervention code [1] 298197 0
Treatment: Drugs
Comparator / control treatment
Comparison of classic and inguinal obturator nerve blocks
Control group
Active

Outcomes
Primary outcome [1] 302269 0
The success rate of classic and inguinal Obturator nerve block approaches will be compared by review of surgical records. (ONB is recorded as ineffective if adductor muscle contractions occurred during the resection.)
Timepoint [1] 302269 0
Each participant is assessed in at the end of the ONB procedure.
Primary outcome [2] 302396 0
The performance speed (The duration of the determination of the obturator nerve) of classic and inguinal Obturator nerve block approaches will be compared by stopwatch timing of procedure by the research assistant.
Timepoint [2] 302396 0
Each participant is assessed in at the end of the ONB procedure.
Secondary outcome [1] 335323 0
The complication risks, such as hematoma or sensory/motor neuronal deficit, of classic and inguinal Obturator nerve block approaches are compared by review of surgical records.
(Vein injuries, hematoma, and complications such as neurologic problems are evaluated during the procedure and 24 hours after the surgery)
Timepoint [1] 335323 0
Each participant is assessed during 24 hours when the ONB procedure is completed.

Eligibility
Key inclusion criteria
Patients who have lateral wall bladder tumor and will be performed the Transurethral resection of bladder tumors (TUR-BT) under spinal anesthesia.
Patients who are American Society of Anesthesiologists (ASA) risk grade I-III and aged between 18-80 years are included in the study.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who had undergone previous surgery in the study region and had anatomic disorders, neurologic problems, muscle disease, and coagulation disorders are excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Simple randomization is done before study commencement by the Excel (Microsoft, Redmond, WA, USA) random number generation function. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by
computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The Statistical Package for the Social Sciences (SPSS) 23.0 (IBM SPSS Inc., Chicago, IL, USA) is used in data analysis. The Chi-square test is used in the comparison of qualitative data in addition to descriptive statistical methods (frequency, percentage, mean, standard deviation). The Kolmogorov-Smirnov and Shapiro-Wilk tests are used in the evaluation of normally distributed data. The independent samples t-test was used to evaluate normally distributed quantitative data, and the Mann-Whitney U test is used in the evaluation of data with no normal distribution. Correlations of variables are evaluated using Pearson’s correlation tests. Probability values less than (P) a=0.05 are regarded as significant and indicating a difference between the groups. Power analysis was performed the G*Power 3.1.9.2 Statistical Package Program; and power (1-ß) is found as 0.90 considering n1=33, n2=33, a=0.05, and effect size as d=0.8.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
30/07/2017
Actual
30/07/2017
Date of last participant enrolment
Anticipated
Actual
1/10/2017
Date of last data collection
Anticipated
Actual
1/10/2017
Sample size
Target
66
Accrual to date
Final
61
Recruitment outside Australia
Country [1] 8926 0
Turkey
State/province [1] 8926 0
Kirsehir

Funding & Sponsors
Funding source category [1] 296596 0
Hospital
Name [1] 296596 0
Ahi Evran University Training and Research Hospital
Country [1] 296596 0
Turkey
Primary sponsor type
Individual
Name
Recai Dagli
Address
Ahi Evran University Faculty of Medicine, Bagbasi Mahallesi, Sht. Sahir Kurutluoglu Cd., 40100 Kirsehir, Turkey.
Country
Turkey
Secondary sponsor category [1] 295549 0
None
Name [1] 295549 0
Address [1] 295549 0
Country [1] 295549 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297823 0
the Clinical Research Ethics Committee of Turgut Ozal University Faculty of Medicine
Ethics committee address [1] 297823 0
Ethics committee country [1] 297823 0
Turkey
Date submitted for ethics approval [1] 297823 0
Approval date [1] 297823 0
09/04/2015
Ethics approval number [1] 297823 0
99950669/104

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 75194 0
A/Prof Recai Dagli
Address 75194 0
Department of Anesthesiology and Reanimation, Ahi Evran University Faculty of Medicine, Bagbasi Campus, 40100, Kirsehir, Turkey,
Country 75194 0
Turkey
Phone 75194 0
+905426536975
Fax 75194 0
Email 75194 0
[email protected]
Contact person for public queries
Name 75195 0
Sahin Bagbanci
Address 75195 0
Department of Urology, Ahi Evran University Faculty of Medicine, Bagbasi Campus, 40100, Kirsehir, Turkey,
Country 75195 0
Turkey
Phone 75195 0
+905054450075
Fax 75195 0
Email 75195 0
[email protected]
Contact person for scientific queries
Name 75196 0
Levent Emir
Address 75196 0
Department of Urology, Ahi Evran University Faculty of Medicine, Bagbasi Campus, 40100, Kirsehir, Turkey,
Country 75196 0
Turkey
Phone 75196 0
+905054579050
Fax 75196 0
Email 75196 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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