NCT00613821

Brief Summary

The purpose of this study is to examine the effect of lidocaine (a numbing medication) inside the uterus on patient pain during an early abortion, compared to the paracervical block (lidocaine injected on either side of the cervix).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable pain

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

2 active sites

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

Study Start

First participant enrolled

September 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
9.3 years until next milestone

Results Posted

Study results publicly available

July 31, 2017

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

8 months

First QC Date

January 31, 2008

Results QC Date

April 29, 2017

Last Update Submit

July 28, 2017

Conditions

Pain

Keywords

surgical abortionpain management

Outcome Measures

Primary Outcomes (1)

  • The Effects of an Intrauterine Lidocaine Infusion to Standard Paracervical Block on Decreasing Patient Pain Measured by Visual Analog Scale in First Trimester Abortions.

    Subjects perception of pain is measured using a 100mm visual analog scale (VAS).The 100mm Pain Visual Analog Scale (VAS) is an instrument used to capture subjective attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of pain by indicating a position along a 100mm continues line: pain scores can range from 0 (no pain) to 100 (worst pain imaginable).

    Immediately (time zero) at uterine aspiration

Study Arms (2)

Lidocaine infusion

EXPERIMENTAL

5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.

Drug: Lidocaine

Paracervical block only

ACTIVE COMPARATOR

Standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed.

Drug: Lidocaine

Interventions

LidocaineDRUG

5 milliliter intrauterine infusion of 4% lidocaine, infusion will be placed slowly over 3 minutes.

Lidocaine infusion

Eligibility Criteria

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

You may qualify if:

  • Good general health
  • Age\>18years
  • English speaking
  • Voluntarily requesting pregnancy termination
  • Have an estimated gestation of up to 76 days since the first day of the preceding menstrual period
  • Confirmed by ultrasound
  • Be able and willing to sign an informed consent
  • Agree to the terms of the study
  • All patients must be premedicated with Ibuprofen and Valium (per clinic protocols)

You may not qualify if:

  • Significant physical or mental health condition
  • A gestational age of 77 days or more
  • Adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease
  • Patients who require or request IV/intramuscular sedation
  • Patients who refuse Ibuprofen, Valium and/or paracervical blocks
  • Patients allergic to lidocaine
  • Patients with known hepatic disease
  • Patients weighing less than 100 lbs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Planned Parenthood of the Columbia Willamette

Portland, Oregon, 96822, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • Edelman A, Nichols MD, Leclair C, Jensen JT. Four percent intrauterine lidocaine infusion for pain management in first-trimester abortions. Obstet Gynecol. 2006 Feb;107(2 Pt 1):269-75. doi: 10.1097/01.AOG.0000194204.71925.4a.

    PMID: 16449111BACKGROUND

MeSH Terms

Conditions

PainAgnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Alison Edelman
Organization
Oregon Health & Science University
whru@ohsu.edu
503-494-3666

Study Officials

  • Alison Edelman, M.D., M.P.H

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 13, 2008

Study Start

September 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

July 31, 2017

Results First Posted

July 31, 2017

Record last verified: 2017-07

Locations

US(2)