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

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

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.

Study Overview

• Status: Completed
• Conditions: IUD Insertion
• Intervention / Treatment: Drug: Vaginal 2% Lidocaine; Drug: Surgical Lubricant Jelly

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Stanford Gynecology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Vaginal 2% Lidocaine; Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
Placebo Comparator: 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.	Drug: Surgical Lubricant Jelly; Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly; Other Names: K-Y Jelly

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Jennifer A Conti, MD, Stanford University

Publications and helpful links

General Publications

• Conti JA, Lerma K, Schneyer RJ, Hastings CV, Blumenthal PD, Shaw KA. Self-administered vaginal lidocaine gel for pain management with intrauterine device insertion: a blinded, randomized controlled trial. Am J Obstet Gynecol. 2019 Feb;220(2):177.e1-177.e7. doi: 10.1016/j.ajog.2018.11.1085. Epub 2018 Nov 13.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): October 19, 2017
• Study Completion (Actual): October 19, 2017

Study Registration Dates

• First Submitted: April 4, 2016
• First Submitted That Met QC Criteria: April 13, 2016
• First Posted (Estimate): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): June 6, 2019
• Last Update Submitted That Met QC Criteria: June 4, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Pain Management; IUD insertion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 32825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No