Clinical trial NCT01411995: Cervical Lidocaine for Intrauterine Device Insertion Pain
Official title: Randomized Controlled Trial of Cervical Lidocaine for Intrauterine Device Insertion Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: intrauterine device
pain
lidocaine gel
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-08-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Pain Score Assessed Immediately Following IUD Insertion
timeFrame: Immediately following IUD insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Division of Clinical Research at Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Colleen P McNicholas, DO
role: PRINCIPAL_INVESTIGATOR
References:
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