N/A
Completed N=50
Paracervical Block Before Intrauterine Device (IUD) Insertion
Pain Control for Intrauterine Device Insertions
Source: ClinicalTrials.gov NCT01207401 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcomePrimary: Median Visual Analogue Score Measuring Pain — 12; 8.5; 12; 28 units on a scale
Summary
The purpose of this study is to evaluate if a paracervical block containing 1% lidocaine administered prior to IUD insertion reduces insertion pain. The hypothesis is that women receiving paracervical analgesia will experience less pain during IUD insertion than those who do not receive such analgesia.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Median Visual Analogue Score Measuring Pain |
12; 8.5; 12; 28; 40; NA | — |
Eligibility Criteria
Inclusion Criteria
- Women age 18 -50 years
- A negative urine pregnancy test and clinically unlikely to be pregnant
- Seeking an intrauterine device for any indication
- Willing and able to sign an informed consent in English
Exclusion Criteria
- History of a prior IUD successful insertion
- Previous failed insertion of an IUD
- Known copper allergy
- Known levonorgestrel allergy
- Known lidocaine allergy
- Current cervicitis
- Pelvic Inflammatory Disease (PID) within 3 months
- Pregnancy within six weeks prior to IUD insertion
- Uterine anomaly or distortion of the uterine cavity
- Use of any other pain medication within 6 hours prior to IUD insertion
- Use of misoprostol within 24 hours prior to IUD insertion
Data sourced from ClinicalTrials.gov (NCT01207401). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.