Self-Administered Lidocaine Gel for Pain Management With IUD Insertion

NCT02738203 | Completed Phase 3 Results

• 1 other identifier: 32825
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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.

Conditions

IUD Insertion

Keywords

Pain Management; IUD insertion

Outcome Measures

Primary Outcomes (1)

• (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 Outcomes (4)

• Anticipated Pain as Measured by a Visual Analog Scale

  30 Minutes prior to procedure

• Baseline Pain as Measured by a Visual Analog Scale

  Immediately prior to procedure; upon arrival to procedure room

• Pain After Speculum Placement as Measured by a Visual Analog Scale

  Intraoperative

• Pain After Tenaculum Placement as Measured by a Visual Analog Scale

  Intraoperative

Study Arms (2)

Experimental, IUD Insertion group

EXPERIMENTAL

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

Control, IUD Insertion group

PLACEBO COMPARATOR

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

Interventions

Vaginal 2% Lidocaine DRUG

Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly

Experimental, IUD Insertion group

Surgical Lubricant Jelly DRUG

Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly

Also known as: K-Y Jelly

Control, IUD Insertion group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Gynecology Clinic

Palo Alto, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 30444982 DERIVED

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine; K-Y jelly

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Research Manager
• Organization: Stanford University, Department of OB/GYN

familyplanningresearch@stanford.edu

6507211562

Study Officials

• Jennifer A Conti, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 14, 2016
• Study Start: June 1, 2016
• Primary Completion: October 19, 2017
• Study Completion: October 19, 2017
• Last Updated: June 6, 2019
• Results First Posted: September 18, 2018

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)