Phase 4
N=40
The Impact of Pain Scores on Intrauterine Lidocaine Versus Normal Saline Infusion at the Time of IUD Placement
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01311102 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Pain Scores During Overall IUD Placement — 2.12; 1.73 units on a scale of 0-9
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lidocaine (Drug); Normal Saline (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Women's Health Care Clinic, Torrance, California
- Primary completion
- Dec 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Scores During Overall IUD Placement |
2.12; 1.73 | — |
| PRIMARY Pain During Tenaculum Placement |
2.20; 2.70 | — |
| PRIMARY Pain Measurement During Liquid Infusion/Sounding |
2.50; 3.39 | — |
| PRIMARY Pain During IUD Placement |
2.95; 3.68 | — |
Summary
The study hypothesis is that infusion of 2% lidocaine at the time of IUD placement will reduce pain scores related to that procedure. In a double blinded randomized trial of 60 women receiving either normal saline or lidocaine infused through an endometrial aspirator, pain scores will be obtained for each step of the IUD placement procedure and for the total experience.
Eligibility Criteria
Inclusion Criteria
- Women eligible for IUD insertion
- Willing to give consent
Exclusion Criteria
- Allergy to lidocaine
- Contraindications to IUD use
Data sourced from ClinicalTrials.gov (NCT01311102). 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.