Clinical trial NCT00617097: Paracervical Block in First Trimester Surgical Abortions
Official title: Paracervical Block With Ketorolac and Lidocaine in First Trimester Surgical Abortions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pain
Surgical Abortion
Keywords: Pain associated with first trimester surgical abortion
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2008-02-15
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Level of Pain During Specific Time Intervals Throughout D&C Procedure.
timeFrame: Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure
Secondary outcomes:
measure: Visual Analogue Scale Regarding Satisfaction Level
timeFrame: end of study (prior to clinic discharge)
measure: Reported Symptoms
timeFrame: end of study (upon discharge from facility after procedure)
measure: Complications
timeFrame: end of study
Other outcomes:
Locations:
city: Portland
country: United States
facility: Planned Parenthood Columbia-Willamette
state: Oregon
Study officials:
affiliation: Johns Hopkins University
name: Johns Hopkins University, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cansino C, Edelman A, Burke A, Jamshidi R. Paracervical block with combined ketorolac and lidocaine in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2009 Dec;114(6):1220-1226. doi: 10.1097/AOG.0b013e3181c1a55b.