Paracervical Block Before Intrauterine Device (IUD) Insertion

N/ACompletedNCT01207401

Northwestern University50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pain Control for Intrauterine Device Insertions

Interventions

LidocaineDRUG

1% Lidocaine

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Northwestern Medical Faculty Foundation or Prentice Ambulatory Care Clinic

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Median Visual Analogue Score Measuring Pain

We asked participants to report their pain score on visual analogue scale (0mm=no pain and 100mm=worse pain possible) at the following time points: 1. Speculum placement 2. Tenaculum placement 3. Paracervical block administration(if subject is in this arm) 4. IUD insertion 5. Five minutes post procedure

Time frame: 1) Speculum placement 2) Tenaculum placement 3) Paracervical block administration(if subject is in this arm) 4) IUD insertion 5) Five minutes post procedure

Data from ClinicalTrials.gov

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