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

Contraception Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03166111
• Other study ID #: LISITU
• Status: Completed
• Phase: Phase 3
• Start date: September 1, 2017
• Est. completion date: May 31, 2020

Study information

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

Clinical Trial Summary

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 216
• Est. completion date: May 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• lidocaine gel
syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion
• placebo gel
syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion

Locations

Country	Name	City	State
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	The difference in pain scores during intrauterine device insertion	using visual analog scale from 0 to 10	10 minutes