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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine gel | Experimental | Instillagel (2% lidocaine) was administered rectally prior to probe insertion. |
|
| Placebo | Placebo Comparator | Placebo (Aquagel) was administered rectally prior to probe insertion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine gel | Drug | Instillagel (2% lidocaine) was administered rectally prior to probe insertion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain assessed by a 10-point visual analogue score | the day of the procedure (transrectal sonography) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taejong Song, MD PhD | Kangbuk Samsung Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kangbuk Samsung Hospital | Seoul | 110-746 | South Korea |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C008129 | chlorhexidine gluconate, lidocaine drug combination |
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| Placebo | Drug | Placebo (Aquagel) was administered rectally prior to probe insertion. |
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