Lidocaine Gel During Transrectal Sonography

Phase 3

Completed

• Conditions: Gynecologic Diseases
• Interventions: Drug: Lidocaine gel; Drug: Placebo

• Registration Number: NCT02567838
• Lead Sponsor: Kangbuk Samsung Hospital

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.

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-24
• Last Update Posted: 2017-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine gel	Lidocaine gel	Instillagel (2% lidocaine) was administered rectally prior to probe insertion.
Placebo	Placebo	Placebo (Aquagel) was administered rectally prior to probe insertion.

Primary Outcome Measures

Name	Time	Method
Pain assessed by a 10-point visual analogue score	the day of the procedure (transrectal sonography)

Secondary Outcome Measures

Name	Time	Method
Number of participants with gel-associated side effect	2 days after the procedure (transrectal sonography)	Information on side effect was collected by phone survey

Trial Locations

Locations (1)

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of