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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
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The intrauterine device (IUD) is a long-acting, highly effective, reversible contraceptive that may be underutilized due to fear of pain during insertion. Although providers frequently prescribe non-steroidal anti-inflammatory drugs (NSAIDs) for IUD insertion, there is no evidence for any pain reduction. In fact, no interventions evaluated in randomized controlled trials have been shown to be effective in reducing pain during IUD insertion. While many women tolerate IUD insertion well, others have moderate to severe pain. This double-blind randomized controlled trial of 150 women aims to estimate the efficacy of intracervical 2% lidocaine gel compared to placebo (KY jelly) to reduce IUD insertion pain. Our hypothesis is that women who are treated with 2% lidocaine gel prior to IUD insertion will have reduced pain as measured on a 0 mm to 100 mm Visual Analog Scale (VAS). We will be able to detect a 15 mm difference on the VAS with our sample size. Other data to be collected include information regarding age, BMI, obstetric history, lactation status, time since pregnancy or delivery, last menstrual period, history of cervical conization, anxiety levels, anticipated pain levels, insertion characteristics (time, difficulty, complications), side effects, and satisfaction with pain control. If 2% lidocaine gel is effective, then a viable, easily administered option for pain control will be available to providers and patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator | Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement. |
|
| Study Group | Experimental | Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2% lidocaine gel | Drug | 120mg lidocaine x 1 |
| |
| Placebo gel |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Pain Score During IUD Insertion | 0 to 100 mm visual analog scale, higher values represent more pain. | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rebecca H Allen, MD, MPH | Women and Infants Hospital of Rhode Island | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Women's Primary Care Center/Women and Infants' Hospital | Providence | Rhode Island | 02905 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24012096 | Derived | Allen RH, Raker C, Goyal V. Higher dose cervical 2% lidocaine gel for IUD insertion: a randomized controlled trial. Contraception. 2013 Dec;88(6):730-6. doi: 10.1016/j.contraception.2013.07.009. Epub 2013 Aug 1. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement. Placebo gel: Inert gel x 1 |
| FG001 | Study Group | Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement. 2% lidocaine gel: 120mg lidocaine x 1 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement. Placebo gel: Inert gel x 1 |
| BG001 | Study Group | Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement. 2% lidocaine gel: 120mg lidocaine x 1 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mean Pain Score During IUD Insertion | 0 to 100 mm visual analog scale, higher values represent more pain. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Will receive placement of inert glycerin gel on ectocervix and in cervical canal prior to IUD placement. Placebo gel: Inert gel x 1 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute complication | Surgical and medical procedures |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rebecca Allen | Women and Infants Hospital | 4012741122 | rhallen@wihri.org |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Drug |
Inert gel x 1 |
|
| Womens Primary Care Center |
| Providence |
| Rhode Island |
| 02905 |
| United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 0 |
| 73 |
| 1 |
| 73 |
| EG001 | Study Group | Will receive placement of 2% lidocaine gel on ectocervix and in cervical canal prior to IUD placement. 2% lidocaine gel: 120mg lidocaine x 1 | 0 | 72 | 1 | 72 |
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