Paracervical Block in First Trimester Surgical Abortions

This study has been completed.
Sponsor:
Collaborator:
Oregon Health and Science University
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00617097
First received: December 28, 2007
Last updated: June 8, 2009
Last verified: June 2009
  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
Abortion, Induced
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:
  • The mean difference in distance (in millimeters) on a 100-mm Visual Analogue Scale (VAS) taken during specific time intervals throughout termination procedure. [ Time Frame: Baseline, Speculum Insertion, at Paracervical block injection, After dialation, End of procedure, 30 minutes after procedure ] [ Designated as safety issue: No ]

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: A
paracervical block with lidocaine
Drug: lidocaine
paracervical block with lidocaine
Experimental: B
paracervical block with ketorolac and lidocaine
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: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00617097     History of Changes
Other Study ID Numbers: NA_00013075, SFP1-1
Study First Received: December 28, 2007
Last Updated: June 8, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on July 20, 2014