Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs

Sponsor

Muğla Sıtkı Koçman University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04638569

Collaborator

(none)

116

Enrollment

Location

Arms

18.5

Anticipated Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Succesful Obturator Nerve Block Bladder Tumor Bleeding	Procedure: obturator nerve block	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

116 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

group 1; Ultrasound-guided obturator nerve block group 2; obturator nerve block with anatomical signsgroup 1; Ultrasound-guided obturator nerve block group 2; obturator nerve block with anatomical signs

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 16, 2021

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

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.

Arm

Intervention/Treatment

Active Comparator: Ultrasound-guided obturator nerve block group

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

Outcome Measures

Primary Outcome Measures

Preoperative succesful obturator nerve block [operation time]
peroperative adductor muscle spazm

Secondary Outcome Measures

peroperative bleeding, Presence of recurrent tumor at postoperative 3rd month [3 months]
peroperative bledding, Control by cystoscopy in the postoperative 3rd month recurrence tumor size

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mugla Sitki Kocman University	Mugla		Turkey	48000

Sponsors and Collaborators

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