Lidocaine In-situ Gel Before Intrauterine Device Insertion

Phase 3

Completed

• Conditions: Pain Relief
• Interventions: Drug: placebo in-situ gel; Drug: lidocaine in-situ gel

• Registration Number: NCT02943135
• Lead Sponsor: Assiut University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-21
• Study First Posted: 2016-10-24
• Study Start: 2017-10-01
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-30
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo in-situ gel	Self-administered gel 10 min before intrauterine device insertion
lidocaine in-situ	lidocaine in-situ gel	Self-administered gel 10 min before intrauterine device insertion

Primary Outcome Measures

Name	Time	Method
Mean pain score during intrauterine device insertion	30 min

Trial Locations

Locations (2)

Ahmed Abbas; 🇪🇬 Assiut, Cairo, Egypt

Assiut University; 🇪🇬 Assiut, Egypt