Self-Administered Lidocaine Gel for Pain Management With IUD Insertion

Phase 3

Completed

• Conditions: IUD Insertion
• Interventions: Drug: Surgical Lubricant Jelly; Drug: Vaginal 2% Lidocaine

• Registration Number: NCT02738203
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-04-04
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-14
• Study Start: 2016-06-01
• Primary Completion: 2017-10-19
• Study Completion: 2017-10-19
• Results First Submitted: 2018-08-07
• Results First Submitted QC: 2018-09-17
• Results First Posted: 2018-09-18
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-04
• Last Update Posted: 2019-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control, IUD Insertion group	Surgical Lubricant Jelly	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.
Experimental, IUD Insertion group	Vaginal 2% Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
(IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion	0-3 minutes after procedure completed	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.

Secondary Outcome Measures

Name	Time	Method
Anticipated Pain as Measured by a Visual Analog Scale	30 Minutes prior to procedure	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.
Baseline Pain as Measured by a Visual Analog Scale	Immediately prior to procedure; upon arrival to procedure room	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.
Pain After Speculum Placement as Measured by a Visual Analog Scale	Intraoperative	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.
Pain After Tenaculum Placement as Measured by a Visual Analog Scale	Intraoperative	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.

Trial Locations

Locations (1)

Stanford Gynecology Clinic; 🇺🇸 Palo Alto, California, United States