Study of Pain Control With Hormonal IUS Insertion
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to compare pain during insertion of the Skyla® IUS using a 100mm visual
      analog scale (VAS) among 92 young women aged 14 to 22 years randomized to receive a
      paracervical (n=46) block versus a sham paracervical block (n=46).
    

Detailed description: 
      Intrauterine systems (IUS) are among the most effective forms of reversible contraception.
      Numerous studies demonstrate their safety and efficacy. Despite this, uptake of IUSs among
      U.S. young women aged 14 to 22 years has been low. Increasing the use of this effective, long
      acting contraception among young women is an important public health goal, as it could help
      to reduce the high rates of unintended pregnancies in this population.

      A major barrier to young women's utilization of IUSs is fear of pain during insertion.
      Unfortunately, studies evaluating methods of pain control during IUS insertion have focused
      on adult women, leaving the question unanswered as to the best pain management method for
      young women. Compared to adult women, young women have less experience with pelvic exams and
      may therefore derive greater benefit from pain control measures during gynecologic
      procedures, such as IUS insertions. Young women and their providers are seeking effective
      pain control options; yet, there is a lack of high quality, comparative effectiveness
      research to guide decision making. This proposal seeks to fill this important gap.

      With the introduction of the Skyla IUS (Bayer Healthcare Pharmaceuticals, Inc.) to the U.S.
      market in January 2013, a new approach to pain management became possible. Skyla is smaller
      than existing IUSs and may therefore cause less pain during insertion. The pain response
      triggered during Skyla insertion may be better controlled by existing pain control options.
      This is the underlying premise of this study.

      In addition to the size of an IUS, theoretical and empirical data suggest that paracervical
      blocks have the greatest promise for pain control during IUS insertion compared to other pain
      control options. Paracervical infiltration of a local anesthetic into the cervix interrupts
      the visceral sensory fibers of the lower uterus, cervix, and upper vagina. Data from several
      clinical trials indicate that paracervical blocks provide clinically significant control of
      pain during multiple types of gynecologic procedures. One recently published study evaluated
      the effectiveness of paracervical blocks during IUS insertion and found a marginally
      significant reduction in pain, but the study was underpowered and focused on adult women. The
      value of a paracervical block in young women receiving an IUS remains unclear.

      The investigator propose to conduct a randomized, controlled single-blind trial comparing
      pain with Skyla IUS insertion among young women aged 14 to 22 years randomized to receive a
      paracervical block versus a sham cervical block. This study will provide important
      information for counseling young women about pain management during IUS insertion.
    

Intervention name(s): Paracervical Nerve Block; Sham Paracervical Block
Intervention type(s): Drug; Drug
Intervention description(s): Block randomization to receive lidocaine paracervical nerve block vs sham cervical block; Block randomization to receive lidocaine paracervical nerve block vs sham cervical block
Other intervention name(s): 1 % Lidocaine; Blunt End of a Q-Tip
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Adolescents; Women's Health; Contraception; Reproduction; Comparative Effectiveness Research; Pregnancy Prevention; Intrauterine Device