Paracervical Block in First Trimester Surgical Abortions

Study Overview
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Brief Summary
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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.

Official Title
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Paracervical Block With Ketorolac and Lidocaine in First Trimester Surgical Abortions

Conditions
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Pain, Surgical Abortion

Intervention / Treatment
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* Drug: lidocaine
* Drug: ketorolac and lidocaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age greater than or equal to 18 years English-speaking ability and willingness to sign the informed consent ability and willingness to comply with the terms of the study voluntary request for pregnancy termination ultrasound-confirmed singleton intrauterine pregnancy with an estimated gestational age not exceeding 76 days (10 6/7 weeks) from the first day of the preceding menstrual cycle Exclusion Criteria: women who require or request sedation untreated acute cervicitis or pelvic inflammatory disease contraindications to lidocaine such as allergy to lidocaine, cardiac arrhythmia or heart block, and porphyria allergic reaction or sensitivity to lorazepam or NSAIDs chronic NSAID use history of gastritis or gastric ulcer acute renal failure or chronic renal disease chronic liver disease history of bleeding diathesis chronic narcotic use current or past history of illegal drug use (excluding marijuana)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: paracervical block with lidocaine<br>Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion | Drug: lidocaine<br>* paracervical block with lidocaine<br>|
| Experimental: paracervical block with ketorolac and lidocaine<br>Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion | Drug: ketorolac and lidocaine<br>* paracervical block with ketorolac and lidocaine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Pain During Specific Time Intervals Throughout D&C 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. | Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale Regarding Satisfaction Level | 100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction) | end of study (prior to clinic discharge) | 
| Reported Symptoms | fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event) | end of study (upon discharge from facility after procedure) | 
| Complications |  | end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain associated with first trimester surgical abortion