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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04638569
Other study ID # 27/12/2019-19/VIII
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 16, 2021
Est. completion date September 1, 2022

Study information

Verified date January 2022
Source Mugla Sitki Koçman University
Contact Eylem Yasar, MD
Phone 00905332392622
Email eylemtarakci@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Comparison of the obturator nerve block in patients undergoing transurethral resection due to bladder tumor, technically using ultrasound guided or blinded with anatomical signs.


Description:

The primary aim of this study is to compare the success rates of ONB techniques performed with ultrasound guided or blind technique. Its secondary purpose is to compare the effect of peroperative bleeding and control cystoscopy performed in the postoperative 3rd month on the presence of recurrent tumor.


Recruitment information / eligibility

Status Recruiting
Enrollment 116
Est. completion date September 1, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - ASA I-II patients Exclusion Criteria: - Tumors that disrupt the integrity of the bladder, - bladder floor tumors, - coagulation disorders, - motor in the lower limbs - with sensory disturbances, - uncooperative patients, - Known allergy to local anesthetics - patients with localized infection at the procedure site

Study Design


Intervention

Procedure:
obturator nerve block
The ultrasound probe will be placed in the middle of the tuberculum pubis and femoral artery, 5-6 cm below the inguinal ligament, and 5 mL of 0.5% bupivacaine will be injected into the anterior and posterior branches of the ON with a needle. In the second group, after the patient is placed in the lithotomy position, 1.5 cm lateral tuberculum pubis and 1.5 cm caudal will be marked and needle entry will be made and 0.5% bupivacaine will be injected with 10 mL. The time elapsed until the first needle insertion and local anesthetic injection is completed will be recorded as the application time.

Locations

Country Name City State
Turkey Mugla Sitki Kocman University Mugla

Sponsors (1)

Lead Sponsor Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Preoperative succesful obturator nerve block peroperative adductor muscle spazm operation time
Secondary peroperative bleeding, Presence of recurrent tumor at postoperative 3rd month peroperative bledding, Control by cystoscopy in the postoperative 3rd month recurrence tumor size 3 months
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