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

NCT ID: NCT02097017

Last Updated: 2020-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-01
• Study Completion Date: 2018-08-01

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.

Conditions

Pain Alleviation; Dilatation and Evacuation; Laminaria Placement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

lidocaine spray group

Group Type: ACTIVE_COMPARATOR

Lidocaine

Intervention Type: DRUG

will local application of lidocaine to the cervix alleviate pain of laminaria insertion

placebo arm

Group Type: PLACEBO_COMPARATOR

placebo comparator

Intervention Type: OTHER

Interventions

Lidocaine

will local application of lidocaine to the cervix alleviate pain of laminaria insertion

Intervention Type: DRUG

placebo comparator

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sheba Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Dr. Avi Shina MD

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sheba Medical Center

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

SHEBA-14-0801-AS-CTIL

Identifier Type: -

Identifier Source: org_study_id