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OpenTrials
Completed

NCT Number: NCT02943135

Lidocaine In-situ Gel Before Intrauterine Device Insertion

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.

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Key information

Conditions

Pain Relief

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Ahmed Abbas, Assiut, Cairo Governorate, Egypt

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lidocaine in-situ gel

Drug

lidocaine in-situ gel

placebo in-situ gel

Drug

placebo in-situ gel

Primary outcomes

  1. Mean pain score during intrauterine device insertion

    Time frame: 30 min

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Oct 24, 2016
Registry last updated
May 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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