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Completed

NCT Number: NCT01411995

Cervical Lidocaine for Intrauterine Device Insertion Pain

The aim of this study is to evaluate intracervical lidocaine gel as a means to decrease pain associated with intrauterine device (IUD) insertion. They will be randomized to either placebo (inert water based lubricating gel) or 2% lidocaine gel to be placed intracervically via angio-catheter just before intrauterine device insertion. Anticipated pain scores will be assessed using a visual analog scale prior to insertion. Using the same pain scale, patients will again be asked at the end of the procedure to rate their pain.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Division of Clinical Research at Washington University

St Louis, Missouri, 63110, United States

About this study

Double blind randomized controlled trial.

Primary outcome: Pain reported on Visual Analog Scale (VAS) Intervention: 2% lidocaine gel at the tenaculum site and intracervical prior to intrauterine device placement

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • age 18-45 yrs
  • selecting intrauterine device contraception
  • able and willing to consent

Exclusion criteria

  • non-English speaking
  • current intrauterine device use
  • expulsion of intrauterine device within 2 weeks
  • allergy to lidocaine or water based lubricant

Treatment and study plan

2% lidocaine gel

Drug

3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to Intrauterine device insertion

Other names: Lidocaine

Water based lubricant

Drug

3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to intrauterine device insertion

Other names: KY gel

Primary outcomes

  1. Pain Score Assessed Immediately Following IUD Insertion

    Time frame: Immediately following IUD insertion

    Using a visual analog scale, women will report their level of pain pre-procedure, after tenaculum placement, and post-procedure (following IUD insertion).The entirety of the procedure should last no more than 5-10 minutes. The pain score is assessed at the 3 timepoints within that 10 minute window. No additional followup is required.

    Range: 0-10 (0= no pain, 10=worst pain)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Randomized Controlled Trial of Cervical Lidocaine for Intrauterine Device Insertion Pain

Acronym: CLIIP

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Aug 8, 2011
Registry last updated
Mar 9, 2018

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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