Clinical trial NCT01466491
Conditions: Pain
Keywords: Pain during first-trimester surgical abortion
Sponsor: Oregon Health and Science University
Start date: 2011-10-01; Completion date: 2013-05-01
Enrollment: 332 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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

Arms: arm 1: The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1). arm 2: The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o'clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1). arm 3: Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation arm 4: Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).
Interventions: intervention 1: Paracervical block technique with lidocaine
Intervention descriptions: intervention 1: 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.

Protocol documents: