Phase 3
N=220
Self-Administered Lidocaine Gel for Pain Management With IUD Insertion
IUD Insertion
Bottom Line
View on ClinicalTrials.gov: NCT02738203 ↗Enrolled (actual)
220
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: (IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion — 65; 59 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Vaginal 2% Lidocaine (Drug); Surgical Lubricant Jelly (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Stanford University
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY (IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion |
65; 59 | — |
| SECONDARY Anticipated Pain as Measured by a Visual Analog Scale |
60; 59 | — |
| SECONDARY Baseline Pain as Measured by a Visual Analog Scale |
2; 2 | — |
| SECONDARY Pain After Speculum Placement as Measured by a Visual Analog Scale |
7; 11 | — |
| SECONDARY Pain After Tenaculum Placement as Measured by a Visual Analog Scale |
30; 38 | — |
Summary
For intrauterine device (IUD) insertion, currently there are no standardized clinical guidelines for pain management. The investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. Reducing pain associated with IUD insertion may benefit patients and providers. When patients are comfortable during their procedure, it is likely the provider can more quickly and with fewer complications perform the insertion. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the standard of care pain management, no intervention, prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.
Eligibility Criteria
Inclusion Criteria
Elective IUD insertion (any type of IUD, copper or hormonal); at an out-patient setting at Stanford; English or Spanish speaking, and ability to give informed consent.
Exclusion Criteria
Any pre-operative use of misoprostol; or use of PO pain control medication (i.e. ibuprofen or acetaminophen) prior to procedure. Allergy to study medications: lidocaine, or surgical lubricant jelly, known uterine anomaly; prior cervical surgery; and no prior use of tampons.
Data sourced from ClinicalTrials.gov (NCT02738203). 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.