Phase 3 Completed N=220 Randomized Double-blind Treatment

Self-Administered Lidocaine Gel for Pain Management With IUD Insertion

IUD insertion

Source: ClinicalTrials.gov NCT02738203 ↗

Enrolled (actual)

220

Serious AEs

0.0%

Results posted

Sep 2018

Primary outcomePrimary: (IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion — 65; 59 score on a scale

◆ Published Evidence

Established

25citations · ~4 / year

Self-administered vaginal lidocaine gel for pain management with intrauterine device insertion: a blinded, randomized controlled trial.

American journal of obstetrics and gynecology · 2019 · Open access · Likely link

Full text ↗ PubMed 30444982 ↗

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.

Linked Publications

Self-administered vaginal lidocaine gel for pain management with intrauterine device insertion: a blinded, randomized controlled trial.

American journal of obstetrics and gynecology · 2019 · 25 citations · Open access · Likely link

Full text ↗PubMed 30444982 ↗

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	—

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02738203) and the linked publication. 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.