NCT01541293

Brief Summary

This is a study to investigate whether instilling a small amount of liquid lidocaine into the uterus will decrease pain felt by women during laminaria insertions done for cervical dilation prior to second trimester abortion. The investigators hypothesize that women who receive intrauterine lidocaine in addition to a paracervical block will experience less pain than women who receive only a paracervical block.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 29, 2012

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

May 14, 2014

Status Verified

October 1, 2013

Enrollment Period

1.1 years

First QC Date

February 23, 2012

Last Update Submit

May 13, 2014

Conditions

Abortion, InducedPain Management

Keywords

Abortion, InducedLaminariaPain managementCervical preparationDilation and Evacuation

Outcome Measures

Primary Outcomes (1)

  • Patient self-report of pain score during laminaria insertion, scored on a 100mm Visual Analog Scale

    Immediately following laminaria insertion

Secondary Outcomes (1)

  • Patient self-report of maximum recalled pain during interval between laminaria insertion and abortion procedure, scored on a 100mm Visual Analog Scale

    24-48 hours after laminaria insertion

Study Arms (2)

Intrauterine Lidocaine

EXPERIMENTAL

The experimental arm will receive 100mg lidocaine (5mL of 2% concentration) instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.

Drug: Lidocaine

Intrauterine Saline

PLACEBO COMPARATOR

Placebo arm will receive 5mL of normal saline instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.

Drug: Normal Saline

Interventions

LidocaineDRUG

100mg of liquid lidocaine, single dose, instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.

Intrauterine Lidocaine
Normal SalineDRUG

5mL of normal saline, instilled into the uterus via a flexible trans-cervical catheter immediately prior to laminaria insertion.

Intrauterine Saline

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Can sign informed consent
  • Healthy pregnant females
  • Weight over 45kg
  • Seeking abortion by dilation and evacuation in the second trimester of pregnancy
  • Gestational age 14-24 weeks confirmed by clinic ultrasound

You may not qualify if:

  • Known allergy or previous reaction to lidocaine, bupivicaine or other anesthetic agent
  • Known allergy or previous reaction to ibuprofen or other NSAID

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

  • Mercier RJ, Liberty A. Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial. Contraception. 2014 Dec;90(6):594-600. doi: 10.1016/j.contraception.2014.07.008. Epub 2014 Jul 23.

    PMID: 25139724DERIVED

MeSH Terms

Conditions

AgnosiaDilatation, Pathologic

Interventions

LidocaineSaline Solution

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Rebecca J Mercier, MD MPH

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2012

First Posted

February 29, 2012

Study Start

September 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

May 14, 2014

Record last verified: 2013-10

Locations

US(1)