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Nonsteroidal Anti-inflammatory Drug (NSAID)

paracervical block with ketorolac and lidocaine for Pain

Phase 2 & 3
Waitlist Available
Led By Johns Hopkins University, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, speculum insertion, at paracervical block injection, after dilation, end of procedure, 30 minutes after procedure
Awards & highlights

Study 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.

Eligible Conditions
  • Pain
  • Abortion

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of study (prior to clinic discharge)
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of study (prior to clinic discharge) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Level of Pain During Specific Time Intervals Throughout D&C Procedure.
Secondary outcome measures
Complications
Reported Symptoms
Visual Analogue Scale Regarding Satisfaction Level

Side effects data

From 2009 Phase 2 & 3 trial • 50 Patients • NCT00617097
12%
reported symptoms
100%
80%
60%
40%
20%
0%
Study treatment Arm
Paracervical Block With Lidocaine
Paracervical Block With Ketorolac and Lidocaine

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: paracervical block with ketorolac and lidocaineExperimental Treatment1 Intervention
Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
Group II: paracervical block with lidocaineActive Control1 Intervention
Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine
FDA approved

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,283 Previous Clinical Trials
14,842,422 Total Patients Enrolled
21 Trials studying Pain
2,367 Patients Enrolled for Pain
Oregon Health and Science UniversityOTHER
983 Previous Clinical Trials
7,385,404 Total Patients Enrolled
17 Trials studying Pain
1,431 Patients Enrolled for Pain
Johns Hopkins University, MDPrincipal InvestigatorJohns Hopkins University
~3 spots leftby Jun 2025