Analgesia for Insertion of Intrauterine Contraception
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
86 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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