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Paracervical Block in First Trimester Surgical Abortions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00617097
Recruitment Status : Completed
First Posted : February 15, 2008
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2017
Oregon Health and Science University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pain Surgical Abortion Drug: lidocaine Drug: ketorolac and lidocaine Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Paracervical Block With Ketorolac and Lidocaine in First Trimester Surgical Abortions
Study Start Date : January 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: paracervical block with lidocaine
Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
Drug: lidocaine
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

Primary Outcome Measures :
  1. 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 ]

    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 :
  1. Visual Analogue Scale Regarding Satisfaction Level [ Time Frame: end of study (prior to clinic discharge) ]
    100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction)

  2. Reported Symptoms [ Time Frame: end of study (upon discharge from facility after procedure) ]
    fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event)

  3. Complications [ Time Frame: end of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00617097

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United States, Oregon
Planned Parenthood Columbia-Willamette
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Johns Hopkins University
Oregon Health and Science University
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Principal Investigator: Johns Hopkins University, MD Johns Hopkins University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Johns Hopkins University Identifier: NCT00617097    
Other Study ID Numbers: NA_00013075
SFP1-1 ( Other Grant/Funding Number: Society of Family Planning )
First Posted: February 15, 2008    Key Record Dates
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2017
Last Verified: August 2017
Keywords provided by Johns Hopkins University:
Pain associated with first trimester surgical abortion
Additional relevant MeSH terms:
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Ketorolac Tromethamine
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors