Paracervical Block Before Intrauterine Device (IUD) Insertion

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine administered prior to IUD insertion reduces insertion pain. The hypothesis is that women receiving paracervical analgesia will experience less pain during IUD insertion than those who do not receive such analgesia.

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Detailed Description

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Conditions

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Pain Control for Intrauterine Device Insertions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Paracervical Block

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

1% Lidocaine

No Paracervical Block

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lidocaine

1% Lidocaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Women age 18 -50 years
* A negative urine pregnancy test and clinically unlikely to be pregnant
* Seeking an intrauterine device for any indication
* Willing and able to sign an informed consent in English

Exclusion Criteria

* History of a prior IUD successful insertion
* Previous failed insertion of an IUD
* Known copper allergy
* Known levonorgestrel allergy
* Known lidocaine allergy
* Current cervicitis
* Pelvic Inflammatory Disease (PID) within 3 months
* Pregnancy within six weeks prior to IUD insertion
* Uterine anomaly or distortion of the uterine cavity
* Use of any other pain medication within 6 hours prior to IUD insertion
* Use of misoprostol within 24 hours prior to IUD insertion

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes