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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine | Experimental | Paracervical block using 15 mL of 1 % lidocaine |
|
| Placebo | Placebo Comparator | paracervical block using 15 mL of bacteriostatic saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Bayview Medical Center | Baltimore | Maryland | 21224 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Aniline Compounds |
| D000588 | Amines |