Planned Parenthood Columbia-Willamette
Portland, Oregon, 97239, United States
NCT Number: NCT00617097
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.
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Notify Me18 year–50 year
Female
Interventional
Phase 2 / Phase 3
Portland, Oregon, 97239, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
paracervical block with lidocaine
paracervical block with ketorolac and lidocaine
Time frame: Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure
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.
Time frame: end of study (prior to clinic discharge)
100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction)
Time frame: end of study (upon discharge from facility after procedure)
fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event)
Time frame: end of study
Johns Hopkins University
Other
Paracervical Block With Ketorolac and Lidocaine in First Trimester Surgical Abortions
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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