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

Phase 4

Completed

• Conditions: Pain Alleviation; Dilatation and Evacuation; Laminaria Placement
• Interventions: Drug: Lidocaine; Other: placebo comparator

• Registration Number: NCT02097017
• Lead Sponsor: Sheba Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-23
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-26
• Study Start: 2016-07-01
• Primary Completion: 2018-08-01
• Study Completion: 2018-08-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-24
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 134

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
lidocaine spray group	Lidocaine	-
placebo arm	placebo comparator	-

Primary Outcome Measures

Name	Time	Method
Pain immediately after inserton of first laminaria	immediately after first laminaria insertion	Women's reported VAS pain score immediately after the insertion of the first laminaria.

Secondary Outcome Measures

Name	Time	Method
Reported pain afer speculum removal, 15 minutes after speculum inserion and before D&E	After speculum removal, 15 minutes after speculum insertion and before D&E	Reported VAS pain at speculum removal, 15 minutes after speculum insertion and before D\&E

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel