Randomized Controlled Trial of Cervical Lidocaine for Intrauterine Device Insertion Pain
Overview
- Phase
- Not Applicable
- Intervention
- 2% lidocaine gel
- Conditions
- Pain
- Sponsor
- Washington University School of Medicine
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Pain Score Assessed Immediately Following IUD Insertion
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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
Investigators
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
Arms & Interventions
2% Lidocaine gel
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
Intervention: 2% lidocaine gel
Water based lubricant
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
Intervention: Water based lubricant
Outcomes
Primary Outcomes
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)