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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

February 23, 2012
April 2, 2013
September 2012
June 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01541293 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Intrauterine Lidocaine for Laminaria
Intrauterine Lidocaine for Pain Control During Laminaria Insertion Prior to Dilation & Evacuation (D&E)

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Abortion, Induced
  • Pain Management
  • Drug: Lidocaine
    100mg of liquid lidocaine, single dose, 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.
  • 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.
    Intervention: Drug: Lidocaine
  • 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.
    Intervention: Drug: Normal Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
72
June 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact: Rebecca J Mercier, MD MPH 919 216 4846 rmercier@med.unc.edu
United States
 
NCT01541293
11-1928
Yes
University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
Not Provided
Principal Investigator: Rebecca J Mercier, MD MPH University of North Carolina, Chapel Hill
University of North Carolina, Chapel Hill
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP