Paracervical Block in First Trimester Surgical Abortions

Phase 2

Completed

Conditions: Pain
Surgical Abortion

Interventions: Drug: ketorolac and lidocaine
Drug: lidocaine

Registration Number: NCT00617097

Lead Sponsor: Johns Hopkins University

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 50

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paracervical block with ketorolac and lidocaine	ketorolac and lidocaine	Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
paracervical block with lidocaine	lidocaine	Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion

Primary Outcome Measures

Name	Time	Method
Level of Pain During Specific Time Intervals Throughout D&C Procedure.	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.

Secondary Outcome Measures

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