Back to resultsProphylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation
Primary Purpose
Pain Alleviation, Dilatation and Evacuation, Laminaria Placement
Status
Completed
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Lidocaine
placebo comparator
Sponsored by
About this trial
This is an interventional treatment trial for Pain Alleviation focused on measuring lidocaine, laminaria, dilatation and evacuation, pain
Eligibility Criteria
Inclusion Criteria:
• Informed consent
- Women with a gestational age of 12-24 weeks by last menstrual period.
Exclusion Criteria:
• CRL assesed by ultrasound as <10 weeks
- Clinical Uterine size >24 weeks
- Fetus Bi Parietal Diameter > 50 mm
- Known amide allergy
Sites / Locations
- Sheba Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
lidocaine spray group
placebo arm
Arm Description
Outcomes
Primary Outcome Measures
Pain immediately after inserton of first laminaria
Women's reported VAS pain score immediately after the insertion of the first laminaria.
Secondary Outcome Measures
Reported pain afer speculum removal, 15 minutes after speculum inserion and before D&E
Reported VAS pain at speculum removal, 15 minutes after speculum insertion and before D&E
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02097017
Brief Title
Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation
Official Title
Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2016 (Actual)
Primary Completion Date
August 1, 2018 (Actual)
Study Completion Date
August 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
5. Study Description
Brief Summary
To examine whether application of lidocaine spray in cervical preparation for second trimester dilatation and evacuation alleviates pain and is superior to current protocol of preparation without analgesia and superior to placebo.
a double- blind, randomized, placebo- controlled trial, performed at a single tertiary medical center. Eligible participants aged 18 and older and about to undergo dilation & evacuation of the uterus between 12 to 24 weeks of gestation. Participants will be randomized using computer generated allocation to receive 10% Xylocaine (lidocaine group) spray or normal saline 0.9% (placebo group), applied identically topically to the endocervix and ectocervix before laminaria insertion. The primary outcome will be the participant's reported pain score immediately after the first laminaria was inserted as measured on a 10 cm visual analog scale (VAS). Secondary outcomes wiil be reported pain scores at speculum removal, 15 minutes after speculum insertion and immediately before the D&E procedure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain Alleviation, Dilatation and Evacuation, Laminaria Placement
Keywords
lidocaine, laminaria, dilatation and evacuation, pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
lidocaine spray group
Arm Type
Active Comparator
Arm Title
placebo arm
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
will local application of lidocaine to the cervix alleviate pain of laminaria insertion
Intervention Type
Other
Intervention Name(s)
placebo comparator
Primary Outcome Measure Information:
Title
Pain immediately after inserton of first laminaria
Description
Women's reported VAS pain score immediately after the insertion of the first laminaria.
Time Frame
immediately after first laminaria insertion
Secondary Outcome Measure Information:
Title
Reported pain afer speculum removal, 15 minutes after speculum inserion and before D&E
Description
Reported VAS pain at speculum removal, 15 minutes after speculum insertion and before D&E
Time Frame
After speculum removal, 15 minutes after speculum insertion and before D&E
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
• Informed consent
Women with a gestational age of 12-24 weeks by last menstrual period.
Exclusion Criteria:
• CRL assesed by ultrasound as <10 weeks
Clinical Uterine size >24 weeks
Fetus Bi Parietal Diameter > 50 mm
Known amide allergy
Facility Information:
Facility Name
Sheba Medical Center
City
Ramat Gan
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation
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