Intrauterine Lidocaine for Laminaria
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.
|Abortion, Induced Pain Management||Drug: Lidocaine Drug: Normal Saline||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Intrauterine Lidocaine for Pain Control During Laminaria Insertion Prior to Dilation & Evacuation (D&E)|
- 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 ]
|Study Start Date:||September 2012|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|