search
Back to results

Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs

Primary Purpose

Succesful Obturator Nerve Block, Bladder Tumor, Bleeding

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
obturator nerve block
Sponsored by
Muğla Sıtkı Koçman University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Succesful Obturator Nerve Block focused on measuring obturator nerve block, bladder tumor, ultrasonografi, anatomical signs

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Mugla Sitki Kocman UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Ultrasound-guided obturator nerve block group

obtutaror nerve block with anatomical landmarks

Arm Description

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.

Outcomes

Primary Outcome Measures

Preoperative succesful obturator nerve block
peroperative adductor muscle spazm

Secondary Outcome Measures

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

Full Information

First Posted
November 16, 2020
Last Updated
January 24, 2022
Sponsor
Muğla Sıtkı Koçman University
search

1. Study Identification

Unique Protocol Identification Number
NCT04638569
Brief Title
Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs
Official Title
Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs in Patients Undergoing Transurethral Resection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 16, 2021 (Actual)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Muğla Sıtkı Koçman University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Succesful Obturator Nerve Block, Bladder Tumor, Bleeding
Keywords
obturator nerve block, bladder tumor, ultrasonografi, anatomical signs

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
group 1; Ultrasound-guided obturator nerve block group 2; obturator nerve block with anatomical signs
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-guided obturator nerve block group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
obtutaror nerve block with anatomical landmarks
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
obturator nerve block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preoperative succesful obturator nerve block
Description
peroperative adductor muscle spazm
Time Frame
operation time
Secondary Outcome Measure Information:
Title
peroperative bleeding, Presence of recurrent tumor at postoperative 3rd month
Description
peroperative bledding, Control by cystoscopy in the postoperative 3rd month recurrence tumor size
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eylem Yasar, MD
Phone
00905332392622
Email
eylemtarakci@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
eylem yasar
Email
eylemtarakci@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eylem Yaşar
Organizational Affiliation
Muğla Sıtkı Koçman University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ali İhsan Uysal
Organizational Affiliation
Mugla Sitki Kocman University Department of Anesthesia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
İlker Akarken
Organizational Affiliation
Mugla Sitki Kocman University Department of Urology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
basak altiparmak
Organizational Affiliation
Mugla Sitki Kocman University Department of Anesthesia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
semra demirbilek
Organizational Affiliation
Mugla Sitki Kocman University Department of Anesthesia
Official's Role
Study Chair
Facility Information:
Facility Name
Mugla Sitki Kocman University
City
Mugla
ZIP/Postal Code
48000
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eylem Yaşar, MD
Phone
00905332392622
Email
eylemtarakci@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Obturator Nerve Block With Ultrasound Guidance and Anatomical Signs

We'll reach out to this number within 24 hrs