Lidocaine Gel During Transrectal Sonography

March 24, 2017 updated by: Taejong Song, Kangbuk Samsung Hospital

LIdocaine Gel Versus Plain Lubricating Gel for Pain Reduction During Transrectal Sonography (LIPS)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

TRS is the common procedure to diagnose or exclude gynecologic disease in virgin women. This procedure can be associated with significant pain, both on insertion of the ultrasound probe as well as on manipulating the probe. The investigators evaluated a new technique for pain relief during TRS. In all, 80 consecutive subjects undergoing TRS at obstetric and gynecologic department were randomized to receive either lidocaine gel(Instillagel) or placebo(Aquagel) rectally prior to probe insertion. The pain encountered before, during, and after the procedure was graded by the patient on a 10-point visual analogue score. The gel-associated side effect was also evaluated by phone survey after 2 day of procedure. The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain associated with transrectal gynecologic ultrasonography.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 3

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

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

15 years to 80 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lidocaine gel
Instillagel (2% lidocaine) was administered rectally prior to probe insertion.
Drug: Lidocaine gel
Instillagel (2% lidocaine) was administered rectally prior to probe insertion.
Other Names:
  • Instillagel
PLACEBO_COMPARATOR: Placebo
Placebo (Aquagel) was administered rectally prior to probe insertion.
Drug: Placebo
Placebo (Aquagel) was administered rectally prior to probe insertion.
Other Names:
  • Aquagel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain assessed by a 10-point visual analogue score
Time Frame: the day of the procedure (transrectal sonography)
the day of the procedure (transrectal sonography)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with gel-associated side effect
Time Frame: 2 days after the procedure (transrectal sonography)
Information on side effect was collected by phone survey
2 days after the procedure (transrectal sonography)

Collaborators and Investigators

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

Sponsor

Kangbuk Samsung 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)

October 1, 2015

Primary Completion (ACTUAL)

August 1, 2016

Study Completion (ACTUAL)

August 1, 2016

Study Registration Dates

First Submitted

October 1, 2015

First Submitted That Met QC Criteria

October 2, 2015

First Posted (ESTIMATE)

October 5, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-08-022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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