Intrauterine Lidocaine for Laminaria
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|ClinicalTrials.gov Identifier: NCT01541293|
Recruitment Status : Completed
First Posted : February 29, 2012
Last Update Posted : May 14, 2014
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 or disease||Intervention/treatment||Phase|
|Abortion, Induced Pain Management||Drug: Lidocaine Drug: Normal Saline||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||72 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Intrauterine Lidocaine for Pain Control During Laminaria Insertion Prior to Dilation & Evacuation (D&E)|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
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.
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.
- Patient self-report of pain score during laminaria insertion, scored on a 100mm Visual Analog Scale [ Time Frame: Immediately following laminaria insertion ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01541293
|United States, North Carolina|
|University of North Carolina, Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Rebecca J Mercier, MD MPH||University of North Carolina, Chapel Hill|