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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lidocaine spray group | Active Comparator |
| |
| placebo arm | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | will local application of lidocaine to the cervix alleviate pain of laminaria insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain immediately after inserton of first laminaria | Women's reported VAS pain score immediately after the insertion of the first laminaria. | immediately after first laminaria insertion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | After speculum removal, 15 minutes after speculum insertion and before D&E |
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Inclusion Criteria:
• Informed consent
Exclusion Criteria:
• CRL assesed by ultrasound as <10 weeks
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Ramat Gan | Israel |
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| placebo comparator | Other |
|
| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| D010146 | Pain |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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