Cervical Lidocaine for Intrauterine Device Insertion Pain (CLIIP)

The Washington University

Status: Completed

Conditions: Pain

Treatments: Drug: Water based lubricant; Drug: 2% lidocaine gel

Study type: Interventional

Funder types: Other

Identifiers

NCT01411995

201105067

Details and patient eligibility

About

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.

Full description

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

Enrollment: 200 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups, including a placebo group

2% Lidocaine gel

Experimental group

Description:

Women randomized to the Lidocaine arm will receive a total of 3-5cc of 2% gel at the tenaculum site and within the endocervical canal

Treatment:

Drug: 2% lidocaine gel

Water based lubricant

Placebo Comparator group

Description:

Women randomized to the placebo arm will receive a total of 3-5cc of water based lubricant at the tenaculum site and within the the endocervical canal

Treatment:

Drug: Water based lubricant