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



Status:Not yet recruiting
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 45
Updated:4/2/2016
Start Date:December 2013
Contact:Roxanne Jamshidi, MD
Email:rjamshi1@jhmi.edu
Phone:410-550-0336

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

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.

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).

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
We found this trial at
1
site
4940 Eastern Ave
Baltimore, Maryland 21224
(410) 550-0100
Johns Hopkins Bayview Medical Center There is no better story in American medicine in the...
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