Pain Control for Intrauterine Device Placement Using Paracervical Block
Condition: Pain Due to Intrauterine Contraceptive Device
Study type: Interventional

Summary: 
      Intrauterine device (IUD) placement can be painful for patients during and after the
      procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly
      effective long acting reversible contraception. Currently there are no proven effective
      methods for reduction of pain during and after placement of modern IUDs. Paracervical block
      pain may decrease this placement pain.
    

Detailed description: 
      Modern IUDs are highly effective long acting reversible forms of contraception. The Mirena
      IUD is 99.8% effective and the Paragard copper IUD is 99.2% effective in preventing
      pregnancy. Fear of IUD placement can be a barrier to obtaining this highly effective form of
      birth control. The current standard of care for pain management during and after IUD
      placement is no medication, as randomized control trials published to date have limited data
      regarding use of medications to decrease pain. There has been one trial to suggest that the
      use of naproxen with 1% lidocaine paracervical block (PCB) compared to PCB alone may decrease
      pain after IUD placement in primarily nulliparous patients. However, this study was with the
      much wider and no longer available Dalkon Shield IUD. In addition, this study did not show
      any significant decrease in pain scores during IUD placement. Studies to evaluate
      effectiveness of ibuprofen and misoprostol have shown no significant decrease in pain scores
      during and after IUD insertion, although the majority of participants in these studies were
      multiparous. There is some suggestion that 2% lidocaine gel one minute prior to IUD insertion
      may have some decrease in pain, although this study was poorly designed.

      Although there is no standard of care in regards to pain medication administration prior to
      IUD placement, providers often suggest paracervical prior IUD insertion among nulliparous
      women. Therefore the primary aim of this study is to determine whether a paracervical block
      (PCB) decreases pain associated with intrauterine device (IUD) placement compared to no
      paracervical block. We hypothesize that administration of a PCB of 20 mL 1% buffered
      lidocaine prior to IUD placement will decrease pain scores by at least 20mm on a visual
      analog scale at various time points during IUD placement when compared to no paracervical
      block.
    

Intervention name(s): Paracervical Block (PCB); No Paracervical Block (Sham PCB)
Intervention type(s): Procedure; Procedure
Intervention description(s): Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.
IUD placement then proceeds; Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.
IUD placement then proceeds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Contraception; Pain; Intrauterine Device; Paracervical Block