NCT02567838

Brief Summary

The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal ultrasonography (TRS) in gynecologic field.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2015

Shorter than P25 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 5, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

10 months

First QC Date

October 1, 2015

Last Update Submit

March 24, 2017

Conditions

Gynecologic Diseases

Outcome Measures

Primary Outcomes (1)

  • Pain assessed by a 10-point visual analogue score

    the day of the procedure (transrectal sonography)

Secondary Outcomes (1)

  • Number of participants with gel-associated side effect

    2 days after the procedure (transrectal sonography)

Study Arms (2)

Lidocaine gel

EXPERIMENTAL

Instillagel (2% lidocaine) was administered rectally prior to probe insertion.

Drug: Lidocaine gel

Placebo

PLACEBO COMPARATOR

Placebo (Aquagel) was administered rectally prior to probe insertion.

Drug: Placebo

Interventions

Lidocaine gelDRUG

Instillagel (2% lidocaine) was administered rectally prior to probe insertion.

Also known as: Instillagel
Lidocaine gel
PlaceboDRUG

Placebo (Aquagel) was administered rectally prior to probe insertion.

Also known as: Aquagel
Placebo

Eligibility Criteria

Age15 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All virgin women who were scheduled to undergo transrectal sonography invited to participate.

You may not qualify if:

  • Allergy to lidocaine or other local anesthetics;
  • Patients with a chronic pain condition for which they were taking daily pain medications of any kind.
  • A bleeding diathesis and/or anticoagulant treatment;
  • Underlying anal or rectal diseases such as symptomatic hemorrhoid, anal fissure, fistulae or anal stricture;
  • An inability to rate a visual analogue scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

Location

MeSH Terms

Conditions

Genital Diseases, Female

Interventions

chlorhexidine gluconate, lidocaine drug combination

Condition Hierarchy (Ancestors)

Female Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Taejong Song, MD PhD

    Kangbuk Samsung Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 1, 2015

First Posted

October 5, 2015

Study Start

October 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

March 27, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)