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.
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
200
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
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
Division of Clinical Research at Washington University
St Louis, Missouri, United States
Pain Score Assessed 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)
Time frame: Immediately following IUD insertion
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