NCT01967017

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

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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).

Conditions

• IUD Insertion Complication
• Pain Control

Interventions

Type	Name	Description
DRUG	Lidocaine
DRUG	Placebo

Timeline

• Start date: 2014-06-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2013-10-22
• Last updated: 2017-06-12

Locations

1 site across 1 country: United States