NCT02228330

Brief Summary

The aim of this study is to estimate the incidence rate of obturator nerve reflex and leg jerking during Transurethral Resections of Bladder Tumors (TURBTs), evaluate the efficacy of obturator nerve block in the prevention of inadvertent muscle spasm, and to identify predictors for both the jerking reflex and successful nerve block.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 4, 2014

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 29, 2014

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

October 17, 2017

Status Verified

October 1, 2017

Enrollment Period

4.3 years

First QC Date

August 4, 2014

Last Update Submit

October 15, 2017

Conditions

Malignant Neoplasm of Urinary Bladder

Keywords

Transurethral resection of bladder tumorsObturator nerve reflexObturator nerve block

Outcome Measures

Primary Outcomes (1)

  • efficacy of obturator nerve block in preventing inadvertent obturator jerk

    percentage of subjects for which the obtorator nerve block prevnted inadvertent obturator jerk

    intraoperative

Secondary Outcomes (1)

  • incidence rate of obturator nerve jerk reflex

    end of study (one year)

Study Arms (1)

uni-lateral obturator nerve block

EXPERIMENTAL

Patients scheduled for TUR for bladder tumor Intervention: uni-lateral obturator nerve block. non-blocked obtorator side of each patient will be used as control

Procedure: obturator nerve block

Interventions

obturator nerve blockPROCEDURE

a uni-lateral obturator nerve block will be performed under ultrasound guidance- using 2% lidocaine for obtaining a short term block.

uni-lateral obturator nerve block

Eligibility Criteria

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

You may qualify if:

  • Adult patient, older than 18 yo, scheduled for TUR for bladder tumor.
  • The subject is willing and able to read, understand and sign the study specific informed consent form.

You may not qualify if:

  • Patients with known coagulopathy, including patients receiving antithrombotic or thrombolytic therapy not in compliance with standard precautions.
  • Patients with a known allergy to anesthetics.
  • Patients who underwent partial cystectomy.
  • Patients with tumors involving bladder diverticula.
  • Patients with pre-existing obturator nerve injury or pre-existing neurologic deficits.
  • Patients with neuromuscular disease.
  • Patients with local infection above planned ONB site.
  • Patients in whom the use of muscle relaxants is deemed necessary by the anesthesiologist.
  • Patients with inguinal lymphadenopathy.
  • Patients unable to sign an informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, 4941492, Israel

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 Officials

  • David Margel, MD, PhD

    Rabin Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2014

First Posted

August 29, 2014

Study Start

July 1, 2014

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

October 17, 2017

Record last verified: 2017-10

Locations

IL(1)