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

NCT02097017 | Completed Phase 4

• 1 other identifier: SHEBA-14-0801-AS-CTIL
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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

Keywords

lidocaine; laminaria; dilatation and evacuation; pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

lidocaine spray group

ACTIVE COMPARATOR

Drug: Lidocaine

placebo arm

PLACEBO COMPARATOR

Other: placebo comparator

Interventions

Lidocaine DRUG

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

lidocaine spray group

placebo comparator OTHER

placebo arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Informed consent
• Women with a gestational age of 12-24 weeks by last menstrual period.

You may not qualify if:

• CRL assesed by ultrasound as \<10 weeks
• Clinical Uterine size \>24 weeks
• Fetus Bi Parietal Diameter \> 50 mm
• Known amide allergy

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba Medical Center

Ramat Gan, Israel

Location

MeSH Terms

Conditions

Dilatation, Pathologic; Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 23, 2014
• First Posted: March 26, 2014
• Study Start: July 1, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: May 27, 2020

Record last verified: 2020-05

Locations

IL (1)