Self-Administered Lidocaine Gel for Pain Management With IUD Insertion

Study Overview
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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.

Official Title
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Self-Administered Lidocaine Gel for Pain Management With IUD Insertion: A Randomized Controlled Trial

Conditions
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IUD Insertion

Intervention / Treatment
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* Drug: Vaginal 2% Lidocaine
* Drug: Surgical Lubricant Jelly


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental, IUD Insertion group<br>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. | Drug: Vaginal 2% Lidocaine<br>* Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly<br>|
| Placebo Comparator: Control, IUD Insertion group<br>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. | Drug: Surgical Lubricant Jelly<br>* Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly<br>* Other names: K-Y Jelly;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion | Pain immediately after speculum removal as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain. | 0-3 minutes after procedure completed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anticipated Pain as Measured by a Visual Analog Scale | Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain. | 30 Minutes prior to procedure | 
| Baseline Pain as Measured by a Visual Analog Scale | Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain. | Immediately prior to procedure; upon arrival to procedure room | 
| Pain After Speculum Placement as Measured by a Visual Analog Scale | Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain. | Intraoperative | 
| Pain After Tenaculum Placement as Measured by a Visual Analog Scale | Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain. | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain Management, IUD insertion