Lidocaine Gel During Transrectal Sonography

Gynecologic Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02567838
• Other study ID #: 2015-08-022
• Status: Completed
• Phase: Phase 3
• First received: October 1, 2015
• Last updated: March 24, 2017
• Start date: October 2015
• Est. completion date: August 2016

Study information

• Verified date: March 2017
• Source: Kangbuk Samsung Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Genital Diseases, Female
• Gynecologic Diseases

Intervention

Drug:
• Lidocaine gel
Instillagel (2% lidocaine) was administered rectally prior to probe insertion.
• Placebo
Placebo (Aquagel) was administered rectally prior to probe insertion.

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Kangbuk Samsung Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessed by a 10-point visual analogue score		the day of the procedure (transrectal sonography)
Secondary	Number of participants with gel-associated side effect	Information on side effect was collected by phone survey	2 days after the procedure (transrectal sonography)