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

Assiut University

Status and phase

Completed

Phase 3

Conditions

Contraception

Treatments

Drug: placebo gel

Drug: lidocaine gel

Study type

Interventional

Funder types

Other

Identifiers

NCT03166111

LISITU

Details and patient eligibility

About

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 .

Enrollment

216 patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

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