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NCT01292447 · ClinicalTrials.gov registry record · NA
A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion
A NA study, sponsored by Women and Infants Hospital of Rhode Island.
- Completed
- Registry status
- NA
- Development phase
- 150
- Enrollment target
NCT01292447 is a NA study that has completed, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 150 participants.
The verdict
NCT01292447, a NA study, has completed, sponsored by Women and Infants Hospital of Rhode Island.
- COMPLETED
- Registry status
- NA
- Development phase
- 150 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo gel
- DRUG 2% lidocaine gel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01292447
The ClinicalTrials.gov registry entry for NCT01292447 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Women and Infants Hospital of Rhode Island, which has 65 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo gel is the first listed.
NCT01292447 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01292447 about?
NCT01292447 is a clinical study titled "A Trial of 2% Lidocaine Gel for Intrauterine Device (IUD) Insertion". 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 reduc...
What is the current status of trial NCT01292447?
This trial is currently completed. It is a NA study. The enrollment target is 150 participants. The study started on 2011-02. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01292447?
The interventions under investigation include: Placebo gel (DRUG), 2% lidocaine gel (DRUG).
Who is sponsoring clinical trial NCT01292447?
This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.
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