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Intrauterine Lidocaine for Laminaria

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01541293
First Posted: February 29, 2012
Last Update Posted: May 14, 2014
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.
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill
February 23, 2012
February 29, 2012
May 14, 2014
September 2012
October 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 ]
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 ]
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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
October 2013
October 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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01541293
11-1928
Yes
Not Provided
Not Provided
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
October 2013

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