10% Lidocaine Spray for Intrauterine Device Insertion

Study Overview
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Brief Summary
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Intrauterine device (IUD) insertion is a procedure that can cause pain. Fear of pain during IUD insertion is a barrier to use of this method. Currently, there is no recommended standard method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection, could reduce pain during IUD insertion, but there is limited data on effect of lidocaine spray on reducing pain during insertion of IUD.

Detailed Description
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Intrauterine device (IUD) is a high efficacy long-acting reversible contraceptive method. However, IUD insertion is a procedure that require well-trained medical personnel and can cause pain in several steps during insertion such as applying tenaculum, applying uterine sound and insertion of IUD. Fear of pain during IUD insertion is a barrier to use of this contraceptive method. Previous researches reported mean pain score with using visual analog scale (VAS) moderated pain (4.7/10 and 34.7-51.2/100). In several countries, pain control is used before IUD insertion procedure. Currently, there is no recommended standard method for reducing pain during this procedure. From Cochrane Database 2015, some lidocaine formulations, such as lidocaine spray, lidocaine gel and lidocaine paracervical injection, could reduce pain during IUD insertion, but there is limited data on effect of lidocaine spray on reducing pain during insertion of IUD. Lidocaine is introduced to use for pain relieving in medical procedures with advantages of rapid action and minimal side effects.10% Lidocaine spray is a form of local anesthetic method that use in obstetrics and gynecology procedures and has favorable efficacy in reducing pain. Nevertheless, there were limited studies of 10% Lidocaine spray during IUD insertion. In this study, we investigate pain during IUD insertion using lidocaine spray compared with placebo.

Official Title
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10% Lidocaine Spray for Pain Control During Intrauterine Device Insertion: A Randomized, Double-blinded, Placebo Controlled Trial

Conditions
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Contraception, Intrauterine Device

Intervention / Treatment
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* Drug: lidocaine spray
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Woman who required for Copper T IUD insertion Body mass index 18.5 - 30 kg/m2 Communicable with Thai language New IUD user Exclusion Criteria: Suspicion of pregnancy Puerperal sepsis/Immediate post-septic abortion Untreated abnormal uterine bleeding Uterine anomaly/abnormal pathology distorting the uterine cavity Current pelvic inflammatory disease Untreated cervicitis/vaginitis Wilson's disease Copper allergy known hypersensitivity to local anaesthetic Analgesic or anxiolytic use within the last 24 h before the procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br>10% lidocaine spray | Drug: lidocaine spray<br>* 10% lidocaine spray 4 puffs<br>* Other names: Xylocaine;|
| Placebo Comparator: group B<br>sterile water | Drug: Placebo<br>* Sterile water 4 puffs<br>* Other names: Sterile water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of 10% Lidocaine spray in reducing pain during IUD insertion: visual analog scale | Assessment of pain using visual analog scale 0-10, 0 = minimum and 10 = maximum scores | Immediately after the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects of 10% Lidocaine spray | Presence or absence of side effects | 20 minutes after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intrauterine device, lidocaine spray