IUD Insertion Complication, Pain Control
Conditions
Keywords
Intrauterine device, Paracervical block
Brief 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).
Interventions
DRUGLidocaine
DRUGPlacebo
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at time of IUD insertion | During IUD insertion (no further follow up after patient leaves ofice) | Differences in visual analog scale (VAS) measurements of perceived pain at the time of IUD deployment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain at other time points of pelvic exam | During other steps of pelvic exam up to 15b minutes after IUD inserted (no further follow up after patient leaves office) | Intrapersonal and group differences in VAS measurements of expected pain and other time points |
Other
| Measure | Time frame | Description |
|---|---|---|
| Ease of insertion | Within 15 minutes of IUD insertion | The degree of difficulty of insertion as rated by the provider will be compared between groups. |
Countries
United States
Outcome results
None listed