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

Dilatation and Evacuation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02097017
• Other study ID #: SHEBA-14-0801-AS-CTIL
• Status: Completed
• Phase: Phase 4
• Start date: July 1, 2016
• Est. completion date: August 1, 2018

Study information

• Verified date: May 2020
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: August 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Dilatation and Evacuation
• Laminaria Placement
• Pain Alleviation

Intervention

Drug:
• Lidocaine
will local application of lidocaine to the cervix alleviate pain of laminaria insertion

Other:
• placebo comparator

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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