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Paracervical Block in First Trimester Surgical Abortions

This study has been completed.
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by (Responsible Party):
Catherine Cansino, MD, MPH, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00617097
First received: December 28, 2007
Last updated: October 15, 2014
Last verified: October 2014
  Purpose

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 Intervention Phase
Pain
Surgical Abortion
Drug: lidocaine
Drug: ketorolac and lidocaine
Phase 2
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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)

  • Complications [ Time Frame: end of study ] [ Designated as safety issue: Yes ]

Enrollment: 50
Study Start Date: January 2008
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00617097

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

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Catherine Cansino, MD, MPH, Clinical Instructor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00617097     History of Changes
Other Study ID Numbers: NA_00013075, SFP1-1
Study First Received: December 28, 2007
Results First Received: June 9, 2014
Last Updated: October 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Pain associated with first trimester surgical abortion

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Lidocaine
Analgesics
Analgesics, Non-Narcotic
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 27, 2014