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

Sheba Medical Center

Status and phase: Completed; Phase 4

Conditions: Dilatation and Evacuation; Pain Alleviation; Laminaria Placement

Treatments: Other: placebo comparator; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02097017

SHEBA-14-0801-AS-CTIL

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 2 patient groups, including a placebo group

lidocaine spray group

Active Comparator group

Treatment:

Drug: Lidocaine

placebo arm

Placebo Comparator group

Treatment:

Other: placebo comparator