Lidocaine Gel During Transrectal Sonography

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Gynecologic Diseases

Intervention / Treatment
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* Drug: Lidocaine gel
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocaine gel<br>Instillagel (2% lidocaine) was administered rectally prior to probe insertion. | Drug: Lidocaine gel<br>* Instillagel (2% lidocaine) was administered rectally prior to probe insertion.<br>* Other names: Instillagel;|
| Placebo Comparator: Placebo<br>Placebo (Aquagel) was administered rectally prior to probe insertion. | Drug: Placebo<br>* Placebo (Aquagel) was administered rectally prior to probe insertion.<br>* Other names: Aquagel;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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