Self-Administered Lidocaine Gel for Pain Management With IUD Insertion

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-10-19

Brief Summary

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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.

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Detailed Description

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Conditions

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IUD Insertion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Experimental, IUD Insertion group

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.

Group Type EXPERIMENTAL

Vaginal 2% Lidocaine

Intervention Type DRUG

Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly

Control, IUD Insertion group

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.

Group Type PLACEBO_COMPARATOR

Surgical Lubricant Jelly

Intervention Type DRUG

Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly

Interventions

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Vaginal 2% Lidocaine

Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly

Intervention Type DRUG

Surgical Lubricant Jelly

Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly

Intervention Type DRUG

Other Intervention Names

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K-Y Jelly

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes