Lidocaine In-situ Gel Before Intrauterine Device Insertion

Pain Relief Clinical Trial

Official title:

Effect of Self-administered Lidocaine In-situ Gel on Intrauterine Device Insertion Pain: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02943135
• Other study ID #: LISID
• Status: Completed
• Phase: Phase 3
• Start date: October 1, 2017
• Est. completion date: March 30, 2020

Study information

• Verified date: May 2020
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intrauterine device can cause pain and discomfort in several ways: Use of the tenaculum to grasp the cervix and straighten the uterus for proper insertion; trans-cervical actions including measuring uterine depth, inserting the insertion tube, and removing the tube; and placement of the device in the uterus.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: March 30, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Women not taken analgesics or anxiolytics in the 24 hours prior insertion

• Women not taken misoprostol prior to insertion

• No contraindication to or history of allergic reaction to lidocaine

• Women who will accept to participate in the study

Exclusion Criteria:

• Lidocaine allergy

• Any contraindication to device placement

Related Conditions & MeSH terms

• Pain Relief

Intervention

Drug:
• lidocaine in-situ gel
lidocaine in-situ gel
• placebo in-situ gel
placebo in-situ gel

Locations

Country	Name	City	State
Egypt	Ahmed Abbas	Assiut	Cairo
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean pain score during intrauterine device insertion		30 min