NCT02567838

Lidocaine Gel During Transrectal Sonography

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Kangbuk Samsung Hospital · Academic / Other
• Sex: Female
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gynecologic Diseases

Interventions

Type	Name	Description
DRUG	Lidocaine gel	Instillagel (2% lidocaine) was administered rectally prior to probe insertion.
DRUG	Placebo	Placebo (Aquagel) was administered rectally prior to probe insertion.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2015-10-05
• Last updated: 2017-03-27

Locations

1 site across 1 country: South Korea