Kangbuk Samsung Hospital
Seoul, 110-746, South Korea
NCT Number: NCT02567838
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.
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Notify Me15 year–80 year
Female
Interventional
Phase 3
Seoul, 110-746, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Instillagel (2% lidocaine) was administered rectally prior to probe insertion.
Other names: Instillagel
Placebo (Aquagel) was administered rectally prior to probe insertion.
Other names: Aquagel
Time frame: the day of the procedure (transrectal sonography)
Time frame: 2 days after the procedure (transrectal sonography)
Information on side effect was collected by phone survey
Kangbuk Samsung Hospital
Other
LIdocaine Gel Versus Plain Lubricating Gel for Pain Reduction During Transrectal Sonography (LIPS)
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