Pain Clinical Trial
Official title:
Paracervical Block With Ketorolac and Lidocaine in First Trimester Surgical Abortions
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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