Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one. Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and prostaglandins has been reported with variable degrees of success .

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Key information

Conditions

Contraception

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Assiut University

Asyut, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Non-pregnant women
Women that did not receive any analgesics or misoprostol in the 24 hours prior to insertion
Women who delivered only by caesarean section

Exclusion criteria

Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids
Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use
Allergy to lidocaine.
Women refuse to participate in the study

Treatment and study plan

Lidocaine gel

Drug

syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion

Placebo Gel

Drug

syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion

Primary outcomes

The difference in pain scores during intrauterine device insertion

Time frame: 10 minutes

using visual analog scale from 0 to 10

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Effect of Self-administered Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery: A Randomized Controlled Study

Important dates

Study start: 2017
Primary completion: 2020
Study completion: 2020
First posted: May 24, 2017
Registry last updated: Oct 6, 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.

Published trials that share one or more normalized conditions with this study.

Completed