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

Phase 4

Withdrawn

• Conditions: IUD Insertion Complication; Pain Control
• Interventions: Drug: Lidocaine; Drug: Placebo

• Registration Number: NCT01967017
• Lead Sponsor: Johns Hopkins University

Brief Summary

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.

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 Timeline

• Study First Submitted: 2012-12-11
• Study First Submitted QC: 2013-10-17
• Study First Posted: 2013-10-22
• Study Start: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-09
• Last Update Posted: 2017-06-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lidocaine	Lidocaine	Paracervical block using 15 mL of 1 % lidocaine
Placebo	Placebo	paracervical block using 15 mL of bacteriostatic saline

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States