Analgesia for Insertion of Intrauterine Contraception

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-11-30

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.

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Detailed Description

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Conditions

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Insertion of Intrauterine Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mepivacaine

10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter

Group Type EXPERIMENTAL

Mepivacaine

Intervention Type DRUG

10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter

NaCL

10 ml NaCl 9mg/ml instilled into the uterus through a hydrosonography catheter

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

10 ml of NaCl 0.9 mg/ml instilled into the uterus through a hydrosonography catheter

Interventions

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Mepivacaine

10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter

Intervention Type DRUG

Placebo

10 ml of NaCl 0.9 mg/ml instilled into the uterus through a hydrosonography catheter

Intervention Type DRUG

Other Intervention Names

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Carbocain (R)

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No