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Completed

NCT Number: NCT02567838

Lidocaine Gel During Transrectal Sonography

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.

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Key information

Age range

15 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kangbuk Samsung Hospital

Seoul, 110-746, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine gel

Drug

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

Other names: Instillagel

Placebo

Drug

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

Other names: Aquagel

Primary outcomes

  1. Pain assessed by a 10-point visual analogue score

    Time frame: the day of the procedure (transrectal sonography)

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 5, 2015
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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