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

Phase 3
Completed
Conditions
Contraception
Interventions
Drug: lidocaine gel
Drug: placebo gel
Registration Number
NCT03166111
Lead Sponsor
Assiut University
Brief 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 .

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
216
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
lidocaine grouplidocaine gellidocaine in-situ gel inserted vaginally
placebo groupplacebo gelplacebo gel inserted vaginally
Primary Outcome Measures
NameTimeMethod
The difference in pain scores during intrauterine device insertion10 minutes

using visual analog scale from 0 to 10

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Assiut University

🇪🇬

Assiut, Egypt

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