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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 9 July 2018
Main ID:  ACTRN12617001050347
Date of registration: 18/07/2017
Prospective Registration: Yes
Primary sponsor: Recai Dagli
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
Date of first enrolment: 30/07/2017
Target sample size: 66
Recruitment status: Completed
URL:  http://www.anzctr.org.au/ACTRN12617001050347.aspx
Study type:  Interventional
Study design:  Randomised controlled trial  Parallel
Phase:  Phase 4
Countries of recruitment
Contacts
Key inclusion & exclusion criteria
Health Condition(s) or Problem(s) studied
adductor muscle contractions
bladder tumor
Intervention(s)
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.
Primary Outcome(s)
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Secondary Sponsor(s)
Ethics review
Results
Results available:
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