NCT02097017

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pain Alleviation
• Dilatation and Evacuation
• Laminaria Placement

Interventions

Type	Name	Description
DRUG	Lidocaine	will local application of lidocaine to the cervix alleviate pain of laminaria insertion
OTHER	placebo comparator

Timeline

• Start date: 2016-07-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2014-03-26
• Last updated: 2020-05-27

Locations

1 site across 1 country: Israel