Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the level of pain women experience with a surgical
      abortion and the effect that varying paracervical block techniques might have on that pain.
      These different techniques involve wait time following the injection as well as the number of
      sites injected.
    

Detailed description: 
      The investigators plan to conduct a single-blinded randomized trial of 350 women undergoing
      elective first-trimester surgical abortion. Subjects will be randomized to two different
      paracervical block techniques, but both the medications and the amount of medications will
      remain the same. Subjects will not know to which group they have been randomized as this
      knowledge may affect how much pain is felt.

      Primary Outcome:

      Patient reported pain with cervical dilation during first trimester surgical abortion. Pain
      is measured as mm distance from the left of the 100-mm visual analogue (VAS) scale with the
      anchors 0 = none, 100 mm = worst imaginable (reflecting magnitude of pain) and recorded
      immediately after completion of cervical dilation. The 100-mm VAS scale is a well established
      and validated study instrument.

      Secondary Outcomes:

        1. Socio-demographic and clinical data: age, race, gravidity, parity, gestational age,
           prior vaginal delivery, prior abortion, level of menstrual symptoms

        2. Pain (VAS scale):

             -  anticipated

             -  baseline

             -  with speculum insertion

             -  with placement of the PCB

             -  with aspiration

             -  30 min postoperatively

             -  intrapersonal pain changes (calculated in analysis)

             -  anxiety [baseline] (VAS scale; anchors 0 = none, 100mm = worst imaginable):

             -  of pain

             -  of surgery

             -  satisfaction (VAS scale; anchors 0 = not, 100mm = very satisfied):

             -  with pain control

             -  overall abortion experience

             -  adverse events

             -  need for additional intraoperative and/or postoperative pain medication

             -  participants' belief if they were in the intervention or control group
    

Intervention name(s): Paracervical block technique with lidocaine
Intervention type(s): Drug
Intervention description(s): The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pain during first-trimester surgical abortion