NCT05540847

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
1 day until next milestone

Study Start

First participant enrolled

September 16, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2023

Completed
Last Updated

April 25, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

September 12, 2022

Last Update Submit

April 23, 2023

Conditions

Keywords

obturator nerve blockultrasound guided blockbladder tumor

Outcome Measures

Primary Outcomes (1)

  • Success rate of obturatr nerve block

    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 Outcomes (4)

  • Number of adductor muscle spazms

    Intraoperative period

  • Sensory block

    30 minutes after the intervention

  • Patient satisfaction

    Peroperative period

  • Procedure time

    During the procedure

Study Arms (2)

Ultrasound guided interfascial obturator nerve block

ACTIVE COMPARATOR

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

Ultrasound guided subpectineal obturator nerve block

EXPERIMENTAL

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

Interventions

Interfascial Injection on Ultrasound-guided Obturator Nerve Block

Ultrasound guided interfascial obturator nerve block

Subpectineal Injection on Ultrasound-guided Obturator Nerve Block

Ultrasound guided subpectineal obturator nerve block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lateral wall bladder tumour
  • ASA I-II patients

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Science University Diskapi Yildirim Beyazıt Training and Research Hospital

Yenimahalle, Ankara, 06170, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 15, 2022

Study Start

September 16, 2022

Primary Completion

April 1, 2023

Study Completion

April 23, 2023

Last Updated

April 25, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations