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 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.
Drug: ketorolac and lidocaine
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Paracervical Block With Ketorolac and Lidocaine in First Trimester Surgical Abortions|
- Level of Pain During Specific Time Intervals Throughout D&C Procedure. [ Time Frame: Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure ] [ Designated as safety issue: No ]
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.
- Visual Analogue Scale Regarding Satisfaction Level [ Time Frame: end of study (prior to clinic discharge) ] [ Designated as safety issue: No ]100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction)
- Reported Symptoms [ Time Frame: end of study (upon discharge from facility after procedure) ] [ Designated as safety issue: Yes ]fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event) range: 0 (minimum) to 25 (maximum based on maximum number of participants in each group)
- Complications [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Active Comparator: paracervical block with lidocaine
Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
paracervical block with lidocaine
Experimental: paracervical block with ketorolac and lidocaine
Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
Drug: ketorolac and lidocaine
paracervical block with ketorolac and lidocaine
Please refer to this study by its ClinicalTrials.gov identifier: NCT00617097
|United States, Oregon|
|Planned Parenthood Columbia-Willamette|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Johns Hopkins University, MD||Johns Hopkins University|