Overview

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

Status:
Withdrawn
Trial end date:
2014-06-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Johns Hopkins University
Treatments:
Lidocaine
Criteria
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