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Intrauterine Lidocaine for Laminaria

This study is currently recruiting participants.
Verified April 2013 by University of North Carolina, Chapel Hill
Sponsor:
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT01541293
First received: February 23, 2012
Last updated: April 2, 2013
Last verified: April 2013
History of Changes
  Purpose

This is a study to investigate whether instilling a small amount of liquid lidocaine into the uterus will decrease pain felt by women during laminaria insertions done for cervical dilation prior to second trimester abortion.

The investigators hypothesize that women who receive intrauterine lidocaine in addition to a paracervical block will experience less pain than women who receive only a paracervical block.


Condition Intervention Phase
Abortion, Induced
Pain Management
 Drug: Lidocaine
Drug: Normal Saline
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intrauterine Lidocaine for Pain Control During Laminaria Insertion Prior to Dilation & Evacuation (D&E)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of North Carolina, Chapel Hill:

Primary Outcome Measures:
  • Patient self-report of pain score during laminaria insertion, scored on a 100mm Visual Analog Scale [ Time Frame: Immediately following laminaria insertion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient self-report of maximum recalled pain during interval between laminaria insertion and abortion procedure, scored on a 100mm Visual Analog Scale [ Time Frame: 24-48 hours after laminaria insertion ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: September 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intrauterine Lidocaine
The experimental arm will receive 100mg lidocaine (5mL of 2% concentration) instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.
 Drug: Lidocaine
100mg of liquid lidocaine, single dose, instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.
Placebo Comparator: Intrauterine Saline
Placebo arm will receive 5mL of normal saline instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.
 Drug: Normal Saline
5mL of normal saline, instilled into the uterus via a flexible trans-cervical catheter immediately prior to laminaria insertion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Can sign informed consent
  • Healthy pregnant females
  • Weight over 45kg
  • Seeking abortion by dilation and evacuation in the second trimester of pregnancy
  • Gestational age 14-24 weeks confirmed by clinic ultrasound

Exclusion Criteria:

  • Known allergy or previous reaction to lidocaine, bupivicaine or other anesthetic agent
  • Known allergy or previous reaction to ibuprofen or other NSAID
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01541293

Contacts
Contact: Rebecca J Mercier, MD MPH 919 216 4846 rmercier@med.unc.edu

Locations
United States, North Carolina
University of North Carolina, Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Investigators
Principal Investigator: Rebecca J Mercier, MD MPH University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT01541293     History of Changes
Other Study ID Numbers: 11-1928
Study First Received: February 23, 2012
Last Updated: April 2, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of North Carolina, Chapel Hill:
Abortion, Induced
Laminaria
Pain management
Cervical preparation
Dilation and Evacuation

Additional relevant MeSH terms:
Lidocaine
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

ClinicalTrials.gov processed this record on June 17, 2013