Analgesia for Insertion of Intrauterine Contraception

Study Overview
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Brief Summary
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Use of long acting reversible contraception (LARC) such as implants or intrauterine contraception (IUC) has been shown to reduce repeat abortions. LARCs have the advantage of being independent of user error and are considered to be underused, especially among young individuals where oral methods have high rates of user failure. IUC is often underused in young or nulliparous women due to fear of pain at insertion. 10 ml of mepivacaine (10mg/ml) or 10ml of sodium hydrochloride will be injected into the uterine cavity through a hydrosonography catheter before the tenaculum has been applied but prior to sounding and to insertion of the IUC. The investigators' hypothesis is that instillation of 10 ml (10mg/ml) mepivacaine though a hydrosonography catheter prior to any instrument placement will provide more effective pain relief than instillation of 10 ml placebo (sodium chloride 9mg/ml). Primary objective: To evaluate the difference in pain score at the time of the insertion of the IUC between treatment and control group. Secondary objectives: To evaluate acceptability of the procedure.

Official Title
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Mepivacaine for Pain Relief at Insertion of Intrauterine Contraception

Conditions
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Insertion of Intrauterine Contraception

Intervention / Treatment
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* Drug: Mepivacaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: over 18 years of age and opting for IUC for contraception with a negative pregnancy test willing to participate in the study after it has been explained orally and in written Exclusion Criteria: previous conisation, known cervical stenosis, signs of ongoing genital infection, known uterine abnormality, any condition resulting in bleeding disorder or contraindication to any local anestetic will be excluded

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mepivacaine<br>10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter | Drug: Mepivacaine<br>* 10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter<br>* Other names: Carbocain (R);|
| Placebo Comparator: NaCL<br>10 ml NaCl 9mg/ml instilled into the uterus through a hydrosonography catheter | Drug: Placebo<br>* 10 ml of NaCl 0.9 mg/ml instilled into the uterus through a hydrosonography catheter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain | difference in pain score (VAS)at the time of the insertion of the IUC between treatment and control group. | On day of insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | They will be asked if the would opt to have this type of pain relief were the ever to insert a new IUC (yes/no), if they would recommend this type of pain relief to any other women (yes/no) and to state how the procedure was compared to their expectations (worse/as expected/better). | 30 minutes after insertion |