NCT02085239

Brief Summary

This study will evaluate the potential role of a long acting anesthetic (ropivacaine) in providing an extended period of pain relief for patients undergoing ultrasound guided core biopsy of the breast.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
withdrawn

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

August 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

September 12, 2018

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

March 7, 2014

Last Update Submit

September 10, 2018

Conditions

Pain Management After Breast Biopsy

Keywords

Breast BiopsyUltrasoundLidocaineRopivacaineBreast Lesion

Outcome Measures

Primary Outcomes (1)

  • Change in pain level from baseline to 1 hour

    Amount of pain that patient is feeling at baseline and 1 hour after the procedure

    1 hour after procedure

Secondary Outcomes (4)

  • Change in pain level from 1 hour to 5 hours after procedure

    5 hours

  • Change in pain level from 5 to 10 hours after the procedure

    10 hours after procedure

  • Change in pain level from 10 to 24 hours after procedure

    24 hours after procedure

  • Pathology

    up to 72 hours after procedure

Study Arms (2)

Lidocaine alone

ACTIVE COMPARATOR

Lidocaine: 8-10 ml of Lidocaine by subcutaneous injection

Drug: Lidocaine alone

Lidocaine Ropivacaine

EXPERIMENTAL

Lidocaine Ropivacaine * 8-10 ml of Lidocaine given by subcutaneous injection * 8-10 ml of Ropivacaine given by subcutaneous injection

Drug: Lidocaine Ropivacaine

Interventions

Lidocaine RopivacaineDRUG

* 8-10 ml of Lidocaine given by subcutaneous injection * 8-10 ml of Ropivacaine given by subcutaneous injection

Also known as: Naropin, Ropivacaine HCL
Lidocaine Ropivacaine
Lidocaine aloneDRUG
Lidocaine alone

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with breast lesions recommended for biopsy by physician

You may not qualify if:

  • Patients with breast lesions not recommended for biopsy
  • Patients with allergic reactions to lidocaine, ropivacaine, or related anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mary Jo Cropper Family Center for Breast Care; Bethesda North Hospital

Cincinnati, Ohio, 45242, United States

Location

Related Publications (3)

  • Applied Radiology. Breast biopsy: Anesthesia, bleeding prevention, representative sampling and rad-path concordance. Vol 41.1. Jan 2012

    BACKGROUND

  • Reynolds HE, Jackson VP, Musick BS. Preoperative needle localization in the breast: utility of local anesthesia. Radiology. 1993 May;187(2):503-5. doi: 10.1148/radiology.187.2.8475298.

    PMID: 8475298BACKGROUND

  • Novy DM, Price M, Huynh PT, Schuetz A. Percutaneous core biopsy of the breast: correlates of anxiety. Acad Radiol. 2001 Jun;8(6):467-72. doi: 10.1016/S1076-6332(03)80617-7.

    PMID: 11394538BACKGROUND

MeSH Terms

Interventions

RopivacaineLidocaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesAcetanilides

Study Officials

  • Dean Shanley, MD

    TriHealth Inc.

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2014

First Posted

March 12, 2014

Study Start

August 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

September 12, 2018

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)