Paracervical Block in First Trimester Surgical Abortions
Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
Summary
The investigators primary objective is to study the analgesic effects of combined ketorolac
and lidocaine in a paracervical block compared to preoperative ibuprofen followed by
intra-operative paracervical block with lidocaine alone on women undergoing first trimester
surgical abortions. The investigators hypothesize that women who receive a paracervical block
of combined ketorolac and lidocaine will experience less pain during the procedure based on a
visual analog scale (VAS) compared to those who receive preoperative ibuprofen and a
paracervical block with lidocaine alone.
This randomized, multi-site, placebo-controlled clinical trial will investigate the
difference in perceived pain from first trimester surgical abortions using a paracervical
block of combined ketorolac and lidocaine compared to preoperative ibuprofen and paracervical
block with lidocaine alone. A total of fifty women who are seeking elective surgical
abortions of intrauterine pregnancies less than 11 0/7 weeks' gestation will be recruited
from Johns Hopkins Bayview Medical Center, Planned Parenthood of Maryland in Baltimore,
Maryland and Planned Parenthood Columbia-Willamette in Portland, Oregon. Pain before, during,
and after surgical abortion will be measured using a 100-mm VAS.
The primary outcome of interest is the mean difference in pain level from preoperative
baseline to time after cervical dilation comparing the treatment groups. If the investigators
see greater pain reduction associated with the paracervical block of lidocaine and ketorolac,
adoption of this regimen may improve pain management during first trimester surgical
abortions. If combined ketorolac and lidocaine when administered as a paracervical block is
proven to be efficacious, the need for additional analgesia in first trimester surgical
abortions can be minimized.