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NCT00617097 · ClinicalTrials.gov registry record · Phase 2
Paracervical Block in First Trimester Surgical Abortions
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT00617097: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT00617097 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00617097, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
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.
Primary Outcome
100-mm Visual Analogue Scale (VAS) during specific time intervals of D\&C procedure: minimum: 0 mm (less pain); maximum: 100 mm (more pain) Time intervals include: basline expected level of pain during procedure, after speculum insertion, at paracervical block injection, after dilation, end of procedure, and 30 minutes after procedure.
Interventions
- DRUG lidocaine
- DRUG ketorolac and lidocaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-06 |
| Phase | Phase 2 |
What the finished NCT00617097 record still lists
NCT00617097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which lidocaine is the first listed.
NCT00617097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00617097 about?
NCT00617097 is a clinical study titled "Paracervical Block 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 investi...
What is the current status of trial NCT00617097?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2008-01. Estimated completion is 2009-06.
What interventions are being tested in trial NCT00617097?
The interventions under investigation include: lidocaine (DRUG), ketorolac and lidocaine (DRUG).
Who is sponsoring clinical trial NCT00617097?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00617097's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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