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OpenTrials
Completed

NCT Number: NCT02097017

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

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.

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Key information

Conditions

Pain Alleviation Dilatation and Evacuation Dilatation, Pathologic Laminaria Placement Neurologic Manifestations Pain Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Sheba Medical Center

Ramat Gan, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

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

Placebo Comparator

Other

Primary outcomes

  1. Pain immediately after inserton of first laminaria

    Time frame: immediately after first laminaria insertion

    Women's reported VAS pain score immediately after the insertion of the first laminaria.

Secondary outcomes

  1. Reported pain afer speculum removal, 15 minutes after speculum inserion and before D&E

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Mar 26, 2014
Registry last updated
May 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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