Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation

• Status: Completed
• Trial end date: 2018-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sheba Medical Center
• Treatments: Lidocaine

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