Diclofenac Plus Lidocaine Gel for Pain Relief During Intrauterine Device Insertion(IUD).

Study Overview
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Brief Summary
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The aim of this study is to determine the effectiveness of a combination of diclofenac and lidocaine gel in reducing pain during IUD insertion.

Detailed Description
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Various studies evaluating the use of local anesthetics or misoprostol prior to IUD insertion have mixed results.We think that the combination of diclofenac and lidocaine gel could be more successful in relieving pain during IUD insertion than single therapy.The aim of this study is to determine the effectiveness of a combination of diclofenac and lidocaine gel in reducing pain during IUD insertion.

Official Title
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Diclofenac Plus Lidocaine Gel for Pain Relief During Intrauterine Device (IUD) Insertion. A Randomized Double Blinded Placebo-controlled Study

Conditions
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Pain

Intervention / Treatment
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* Drug: Diclofenac plus lidocaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of reproductive age requesting IUD for contraception Exclusion Criteria: Patients with contraindications to IUD insertion ( less than 6 weeks postpartum, less than 2 weeks after abortion, uterine anomalies, fibroid distorting uterine cavity, pregnancy, pelvic inflammatory disease, cervicitis, uterine depth less than 6 cm or more than 9 cm) , previous IUD insertion, allergy to diclofenac or lidocaine, peptic ulcer , asthma, bleeding disorders, cardiac, liver or kidney diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Diclofenac plus lidocaine<br>Diclofenac(100 mg) is administered 1 hour before IUD insertion and lidocaine gel is placed on cervix three minutes before IUD insertion | Drug: Diclofenac plus lidocaine<br>* The study nurse will instruct the patients to swallow diclofenac tablets (100 mg) 1 hour before IUD insertion. Three millilitres of the lidocaine gel will be placed on the anterior lip of the cervix . A cotton swab socked in 3 ml of the lidocaine gel will be introduced in the cervical canal till the level of internal os. The cotton swab will be left in place for three minutes. The IUD will be inserted by experienced gynecologists according to the recommendations of manufacture.<br>|
| Placebo Comparator: Placebo<br>Placebo tablets is administered 1 hour before IUD insertion and placebo gel is placed on cervix three minutes before IUD insertion | Drug: Placebo<br>* The study nurse will instruct the patients to swallow placebo tablets 1 hour before IUD insertion. Three millilitres of the placebo gel will be placed on the anterior lip of the cervix . A cotton swab socked in 3 ml of the placebo gel will be introduced in the cervical canal till the level of internal os. The cotton swab will be left in place for three minutes. The IUD will be inserted by experienced gynecologists according to the recommendations of manufacture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain |  | Pain intensity will be assessed by visual analogue scale during the procedure [an expected average of 3 minutes] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects of diclofenac and lidocaine |  | Within 24 hours after IUD insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IUD,Diclofenac , Lidocaine