Paracervical Block in First Trimester Surgical Abortions
Public ClinicalTrials.gov record NCT00617097. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Paracervical Block With Ketorolac and Lidocaine in First Trimester Surgical Abortions
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00617097
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 50 Years
- Sex
- Female
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 31, 2007
- Primary completion
- Apr 30, 2009
- Completion
- May 31, 2009
- Last update posted
- Sep 14, 2017
2008 – 2009
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Planned Parenthood Columbia-Willamette | Portland | Oregon | 97239 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00617097, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 14, 2017 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00617097 live on ClinicalTrials.gov.