Study of Local Anesthesia as a Method to Decrease IUD Insertion Related Pain

Phase 4WithdrawnNCT01967017

Johns Hopkins University

Overview

Despite the high efficacy of intrauterine devices (IUDs), some women choose not to receive IUDs secondary to the pain associated with insertion. Nulliparous women may be especially susceptible to procedure-related pain from IUD insertion. This study will investigate the difference in perceived pain from IUD insertion, comparing local anesthesia to a placebo, among women who have not had a vaginal delivery before. The investigators anticipate that among women who have not had a previous vaginal delivery, the pain associated with IUD insertion will be significantly decreased after administration of local anesthesia.

The study will investigate the difference in perceived pain from IUD insertion, comparing paracervical block with lidocaine to a placebo (bacteriostatic saline) block, among nulliparous and "functionally nulliparous" women. The investigators plan a double-masked, placebo controlled, randomized clinical trial. The investigators anticipate that among patients who have not had a previous vaginal delivery, the pain associated with IUD insertion will be significantly decreased after administration of a 15 mL 1% lidocaine paracervical block compared to patients who receive 15 mL of bacteriostatic saline (placebo).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

IUD Insertion Complication Pain Control

Interventions

LidocaineDRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Nulliparous and "functionally nulliparous" women receiving their first IUD. "Functionally nulliparous" women include those who have never had a prior vaginal delivery or who have never experienced previous significant cervical dilation (ie. women who have experienced miscarriages or abortions prior to 24 weeks gestation, and women who have had cesarean sections while not in active labor defined as \<4 cm dilation). * English speaking Exclusion Criteria: * Presence of a Centers for Disease Control Medical Eligibility Criteria for Contraceptive Use category 3 or 4 precaution to a levonorgestrel IUD * chronic narcotic use, current or past history of illegal drug use (excluding marijuana) * allergy to lidocaine

Locations (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Pain at time of IUD insertion

Differences in visual analog scale (VAS) measurements of perceived pain at the time of IUD deployment

Time frame: During IUD insertion (no further follow up after patient leaves ofice)

Secondary Outcomes

Pain at other time points of pelvic exam

Intrapersonal and group differences in VAS measurements of expected pain and other time points

Time frame: During other steps of pelvic exam up to 15b minutes after IUD inserted (no further follow up after patient leaves office)

Data from ClinicalTrials.gov

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