Study of Local Anesthesia as a Method to Decrease IUD Insertion Related Pain
Recruitment status was Not yet recruiting
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Paracervical Block With Lidocaine as a Modality to Decrease IUD Insertion Related Pain|
- Pain at time of IUD insertion [ Time Frame: During IUD insertion (no further follow up after patient leaves ofice) ] [ Designated as safety issue: No ]Differences in visual analog scale (VAS) measurements of perceived pain at the time of IUD deployment
- Pain at other time points of pelvic exam [ Time Frame: During other steps of pelvic exam up to 15b minutes after IUD inserted (no further follow up after patient leaves office) ] [ Designated as safety issue: No ]Intrapersonal and group differences in VAS measurements of expected pain and other time points
- Ease of insertion [ Time Frame: Within 15 minutes of IUD insertion ] [ Designated as safety issue: No ]The degree of difficulty of insertion as rated by the provider will be compared between groups.
|Study Start Date:||December 2013|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Paracervical block using 15 mL of 1 % lidocaine
Placebo Comparator: Placebo
paracervical block using 15 mL of bacteriostatic saline
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01967017
|Contact: Roxanne Jamshidi, MDemail@example.com|
|United States, Maryland|
|Johns Hopkins Bayview Medical Center||Not yet recruiting|
|Baltimore, Maryland, United States, 21224|
|Contact: Nell Molano, CRNP 410-874-1455|