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

Pain Control Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01967017
• Other study ID #: NA_00078756
• Status: Withdrawn
• Phase: Phase 4
• First received: December 11, 2012
• Last updated: June 9, 2017
• Start date: June 2014
• Est. completion date: June 2014

Study information

• Verified date: June 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• IUD Insertion Complication
• Pain Control

Intervention

Drug:
• Lidocaine

• Placebo

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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)