Gynecologic Diseases
Conditions
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.
Interventions
DRUGLidocaine gel
Instillagel (2% lidocaine) was administered rectally prior to probe insertion.
DRUGPlacebo
Placebo (Aquagel) was administered rectally prior to probe insertion.
Sponsors
Kangbuk Samsung Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain assessed by a 10-point visual analogue score | the day of the procedure (transrectal sonography) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with gel-associated side effect | 2 days after the procedure (transrectal sonography) | Information on side effect was collected by phone survey |
Countries
South Korea
Outcome results
None listed