Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs

NCT04638569 | Unknown

• 1 other identifier: 27/12/2019-19/VIII
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Succesful Obturator Nerve Block; Bladder Tumor; Bleeding

Keywords

obturator nerve block; bladder tumor; ultrasonografi; anatomical signs

Outcome Measures

Primary Outcomes (1)

• Preoperative succesful obturator nerve block

  peroperative adductor muscle spazm

  operation time

Secondary Outcomes (1)

• peroperative bleeding, Presence of recurrent tumor at postoperative 3rd month

  3 months

Study Arms (2)

Ultrasound-guided obturator nerve block group

ACTIVE COMPARATOR

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

obtutaror nerve block with anatomical landmarks

ACTIVE COMPARATOR

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

Interventions

obturator nerve block PROCEDURE

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.

Ultrasound-guided obturator nerve block group; obtutaror nerve block with anatomical landmarks

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Muğla Sıtkı Koçman University: lead

Study Sites (1)

Mugla Sitki Kocman University

Muğla, 48000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Hemorrhage

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eylem Yaşar

  Muğla Sıtkı Koçman University

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Central Study Contacts

Eylem Yasar, MD

CONTACT

00905332392622; eylemtarakci@gmail.com

eylem yasar

CONTACT

eylemtarakci@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical doctor of anesthesiology special

Model Details: group 1; Ultrasound-guided obturator nerve block group 2; obturator nerve block with anatomical signs

Study Record Dates

• First Submitted: November 16, 2020
• First Posted: November 20, 2020
• Study Start: February 16, 2021
• Primary Completion: March 1, 2022
• Study Completion: September 1, 2022
• Last Updated: February 7, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)