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

Paracervical Block With Lidocaine as a Modality to Decrease IUD Insertion Related Pain

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.

Study Overview

• Status: Withdrawn
• Conditions: Pain Control; IUD Insertion Complication
• Intervention / Treatment: Drug: Placebo; Drug: Lidocaine

Detailed Description

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
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine; Paracervical block using 15 mL of 1 % lidocaine	Drug: Lidocaine
Placebo Comparator: Placebo; paracervical block using 15 mL of bacteriostatic saline	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at time of IUD insertion	Differences in visual analog scale (VAS) measurements of perceived pain at the time of IUD deployment	During IUD insertion (no further follow up after patient leaves ofice)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain at other time points of pelvic exam	Intrapersonal and group differences in VAS measurements of expected pain and other time points	During other steps of pelvic exam up to 15b minutes after IUD inserted (no further follow up after patient leaves office)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease of insertion	The degree of difficulty of insertion as rated by the provider will be compared between groups.	Within 15 minutes of IUD insertion

Collaborators and Investigators

• Sponsor: Johns Hopkins University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2014
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 11, 2012
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 22, 2013

Study Record Updates

• Last Update Posted (Actual): June 12, 2017
• Last Update Submitted That Met QC Criteria: June 9, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Intrauterine device; Paracervical block
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: NA_00078756