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OpenTrials
Completed

NCT Number: NCT02738203

Self-Administered Lidocaine Gel for Pain Management With IUD Insertion

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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Key information

Conditions

IUD Insertion Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Stanford Gynecology Clinic

Palo Alto, California, 94305, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaginal 2% Lidocaine

Drug

Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly

Surgical Lubricant Jelly

Drug

Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly

Other names: K-Y Jelly

Primary outcomes

  1. (IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion

    Time frame: 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 outcomes

  1. Anticipated Pain as Measured by a Visual Analog Scale

    Time frame: 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.

  2. Baseline Pain as Measured by a Visual Analog Scale

    Time frame: 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.

  3. Pain After Speculum Placement as Measured by a Visual Analog Scale

    Time frame: 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.

  4. Pain After Tenaculum Placement as Measured by a Visual Analog Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Official study title

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

Acronym: SALUD

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 14, 2016
Registry last updated
Jun 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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