Self-Administered Lidocaine Gel for Pain Management With IUD Insertion (SALUD)

Stanford University

Status and phase: Completed; Phase 3

Conditions: IUD Insertion

Treatments: Drug: Vaginal 2% Lidocaine; Drug: Surgical Lubricant Jelly

Study type: Interventional

Funder types: Other

Identifiers

NCT02738203

32825

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 2 patient groups, including a placebo group

Experimental, IUD Insertion group

Experimental group

Description:

If the subject is assigned to the experimental group (vaginal lidocaine jelly): She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.

Treatment:

Drug: Vaginal 2% Lidocaine

Control, IUD Insertion group

Placebo Comparator group

Description:

If the subject is assigned to the control group (sterile, surgical lubricant jelly): •She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo.

Treatment:

Drug: Surgical Lubricant Jelly