Comparison of Interfascial Injection Versus Subpectineal Injection on Ultrasound-guided Obturator Nerve Block

April 23, 2023 updated by: Halil Cihan Kose, Diskapi Teaching and Research Hospital
This study aimed to assess the effectiveness of the ultrasound-guided interfascial injection approach with the subpectineal injection technique for obturator nerve block in bladder cancers undergoing transurethral resection of bladder tumor (TURBT) under spinal anesthesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Ankara
      • Yenimahalle, Ankara, Turkey, 06170
        • Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Lateral wall bladder tumour
  • ASA I-II patients

Exclusion Criteria:

  • Contraindications for spinal anesthesia,
  • Tumors that disrupt the integrity of the bladder,
  • Coagulation disorders,
  • Uncooperative patients,
  • Allergy to local anesthetics.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound guided interfascial obturator nerve block
In supine position, ultrasound probe will be placed on inguinal region, 2-3 cm below to the inguinal crease. Patients in this group will receive interfascial obturator nerve block under ultrasound guidance.
Procedure: Interfascial Injection
Interfascial Injection on Ultrasound-guided Obturator Nerve Block
Experimental: Ultrasound guided subpectineal obturator nerve block
In supine position, the ultrasound probe will be placed on in inguinal region, 1-2 cm below to the inguinal crease to identiy the subpectineal area. Patients in this group will receive subpectineal obturator nerve block under ultrasound guidance.
Procedure: Subpectineal Injection
Subpectineal Injection on Ultrasound-guided Obturator Nerve Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of obturatr nerve block
Time Frame: Peroperative period
The success or fail of the obturator nerve block will be conformed using nerve stimulator. Detecting muscles twitch will br considered to be a fail.
Peroperative period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of adductor muscle spazms
Time Frame: Intraoperative period
Number of adductor muscle spazms in each group will be noted during the intraoperative period.
Intraoperative period
Sensory block
Time Frame: 30 minutes after the intervention
Sensory block area will be evaluated by a pin prick at in the dermatomal areas related obturator nerve and branches.
30 minutes after the intervention
Patient satisfaction
Time Frame: Peroperative period
Changes in overall satisfaction will be assessed using a 5 point Likert Scale ( 1-very dissatisfied, 2- dissatisfied, 3- neutral, 4-satisfied, 5 - very satisfied
Peroperative period
Procedure time
Time Frame: During the procedure
Block performance time will be recorded from the time the first ultrasound image is obtained until the procedure is completed
During the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 16, 2022

Primary Completion (Actual)

April 1, 2023

Study Completion (Actual)

April 23, 2023

Study Registration Dates

First Submitted

September 12, 2022

First Submitted That Met QC Criteria

September 12, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

April 25, 2023

Last Update Submitted That Met QC Criteria

April 23, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 141/09

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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