drugset / Trial / NCT02078063

Analgesia for Insertion of Intrauterine Contraception

NCT02078063

Phase 3 Completed 86 enrolled Karolinska Institutet
RandomizedParallel-groupQuadruple-blindTreatment

Summary

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.

Timeline

Start
2013-11
Primary completion
2017-11
Completion
2017-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Mepivacaine Other / unclassified 10 ml Other

Indications

No indication recorded.