Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion

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

Inclusion Criteria:

- age 18 years or older

- voluntarily requesting pregnancy termination

- ultrasound-confirmed intrauterine pregnancy up to 10 6/7 weeks gestational age

- generally healthy

- English or Spanish speaking

- able or willing to sign an informed consent and agree to terms of the study

Exclusion Criteria:

- gestational age over 10 6/7 weeks (due to routine use of misoprostol starting at this
gestational age at the study sites)

- incomplete abortion

- failed medical abortion

- required or requested IV sedation (prior to randomization)

- patient who declines Ibuprofen, Lorazepam or PCB

- medical contraindication or allergy to any of the study medications

- chronic use of narcotic pain medication or heroin

- significant physical or mental health condition

- adnexal mass or tenderness on pelvic exam consistent with inflammatory disease

- known hepatic disease

- women who, in the opinion of the investigator, are not suitable for the study
protocol