Lidocaine Gel During Transrectal Sonography

Kangbuk Samsung Hospital

Status and phase

Completed

Phase 3

Conditions

Gynecologic Diseases

Treatments

Drug: Placebo

Drug: Lidocaine gel

Study type

Interventional

Funder types

Other

Identifiers

NCT02567838

2015-08-022

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 patients

Sex

Female

Ages

15 to 80 years old

Volunteers

No Healthy Volunteers

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