Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs

Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs in Patients Undergoing Transurethral Resection

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

Study Overview

• Status: Recruiting
• Conditions: Bleeding; Bladder Tumor; Succesful Obturator Nerve Block
• Intervention / Treatment: Procedure: obturator nerve block

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eylem Yaşar, MD; Phone Number: 00905332392622; Email: eylemtarakci@gmail.com
• Study Contact Backup: Name: eylem yasar; Email: eylemtarakci@gmail.com

Study Locations

• Turkey
  • Mugla, Turkey, 48000
    • Recruiting
    • Mugla Sitki Kocman University
    • Contact: Eylem Yaşar, MD; Phone Number: 00905332392622; Email: eylemtarakci@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound-guided obturator nerve block group; 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.	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.
Active Comparator: obtutaror nerve block with anatomical landmarks; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preoperative succesful obturator nerve block	peroperative adductor muscle spazm	operation time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Muğla Sıtkı Koçman University
• Investigators: Principal Investigator: Eylem Yaşar, Muğla Sıtkı Koçman University; Study Chair: Ali İhsan Uysal, Mugla Sitki Kocman University Department of Anesthesia; Study Chair: İlker Akarken, Mugla Sitki Kocman University Department of Urology; Study Chair: basak altiparmak, Mugla Sitki Kocman University Department of Anesthesia; Study Chair: semra demirbilek, Mugla Sitki Kocman University Department of Anesthesia

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2021
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: November 16, 2020
• First Submitted That Met QC Criteria: November 16, 2020
• First Posted (Actual): November 20, 2020

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: obturator nerve block; bladder tumor; ultrasonografi; anatomical signs
• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: 27/12/2019-19/VIII

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No