Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs

NCT ID: NCT04638569

Last Updated: 2022-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

116 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-16

Study Completion Date

2022-09-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Succesful Obturator Nerve Block Bladder Tumor Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

group 1; Ultrasound-guided obturator nerve block group 2; obturator nerve block with anatomical signs
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

obturator nerve block

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

obturator nerve block

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muğla Sıtkı Koçman University

OTHER

Sponsor Role lead

Responsible Party

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Eylem Yaşar

medical doctor of anesthesiology special

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eylem Yaşar

Role: PRINCIPAL_INVESTIGATOR

Muğla Sıtkı Koçman University

Ali İhsan Uysal

Role: STUDY_CHAIR

Mugla Sitki Kocman University Department of Anesthesia

İlker Akarken

Role: STUDY_CHAIR

Mugla Sitki Kocman University Department of Urology

basak altiparmak

Role: STUDY_CHAIR

Mugla Sitki Kocman University Department of Anesthesia

semra demirbilek

Role: STUDY_CHAIR

Mugla Sitki Kocman University Department of Anesthesia

Locations

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Mugla Sitki Kocman University

Muğla, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Eylem Yasar, MD

Role: CONTACT

00905332392622

eylem yasar

Role: CONTACT

Facility Contacts

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Eylem Yaşar, MD

Role: primary

00905332392622

Other Identifiers

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27/12/2019-19/VIII

Identifier Type: -

Identifier Source: org_study_id

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