NCT01217593

Brief Summary

The purpose of this study is to compare ultrasound and predetermined distance techniques for finding the paravertebral space to inject the local anesthetic (numbing medicine) when you are given anesthesia for surgery. The paravertebral space is located on either side of the spinal cord and contains the nerves that provide sensation to the chest wall. The predetermined distance technique is a series of measurements taken to determine the location of the paravertebral space where the local anesthetic is injected. The ultrasound technique uses direct visualization of the local anesthetic being placed in the paravertebral space. This type of anesthesia has many benefits including decreasing your pain after breast surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2010

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 8, 2010

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 21, 2014

Status Verified

March 1, 2014

Enrollment Period

6 years

First QC Date

October 7, 2010

Last Update Submit

March 20, 2014

Conditions

MastectomyBreast Neoplasms

Keywords

mastectomybreast cancerbreast surgery

Outcome Measures

Primary Outcomes (1)

  • Visual analog scores(VAS)for pain and perioperative opioid requirements

    The VAS scores and the opioid consumption will be compared between the ultrasound group and the predetermined distance technique group.

    24 hours

Secondary Outcomes (1)

  • time, incidence of adverse events and patient satisfaction

    24 hours

Study Arms (2)

ultrasound

EXPERIMENTAL

Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.

Procedure: ultrasound

predetermined distance

ACTIVE COMPARATOR

The predetermined distance technique will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.

Procedure: predetermined distance

Interventions

ultrasoundPROCEDURE

Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.

ultrasound
predetermined distancePROCEDURE

The predetermined distance technique will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.

predetermined distance

Eligibility Criteria

Age25 Years - 85 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females age 25 - 85
  • ASA Physical status I-III
  • Scheduled for primary mastectomy
  • Ability to give informed consent

You may not qualify if:

  • Allergy to:
  • Local anesthetics Fentanyl Hydromorphone Propofol Midazolam
  • Patient refusal
  • Infection at the injection site
  • Peripheral Neuropathy
  • Bilateral breast surgery
  • Prior thoracic surgery on surgical side
  • Severe spinal deformity
  • Coagulopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

RECRUITING

Related Publications (9)

  • la Grange P, Foster PA, Pretorius LK. Application of the Doppler ultrasound bloodflow detector in supraclavicular brachial plexus block. Br J Anaesth. 1978 Sep;50(9):965-7. doi: 10.1093/bja/50.9.965.

    PMID: 708565BACKGROUND

  • Marhofer P, Schrogendorfer K, Koinig H, Kapral S, Weinstabl C, Mayer N. Ultrasonographic guidance improves sensory block and onset time of three-in-one blocks. Anesth Analg. 1997 Oct;85(4):854-7. doi: 10.1097/00000539-199710000-00026.

    PMID: 9322469RESULT

  • Domingo-Triado V, Selfa S, Martinez F, Sanchez-Contreras D, Reche M, Tecles J, Crespo MT, Palanca JM, Moro B. Ultrasound guidance for lateral midfemoral sciatic nerve block: a prospective, comparative, randomized study. Anesth Analg. 2007 May;104(5):1270-4, tables of contents. doi: 10.1213/01.ane.0000221469.24319.49.

    PMID: 17456685RESULT

  • Willschke H, Marhofer P, Bosenberg A, Johnston S, Wanzel O, Cox SG, Sitzwohl C, Kapral S. Ultrasonography for ilioinguinal/iliohypogastric nerve blocks in children. Br J Anaesth. 2005 Aug;95(2):226-30. doi: 10.1093/bja/aei157. Epub 2005 May 27.

    PMID: 15923270RESULT

  • Oberndorfer U, Marhofer P, Bosenberg A, Willschke H, Felfernig M, Weintraud M, Kapral S, Kettner SC. Ultrasonographic guidance for sciatic and femoral nerve blocks in children. Br J Anaesth. 2007 Jun;98(6):797-801. doi: 10.1093/bja/aem092. Epub 2007 Apr 21.

    PMID: 17449890RESULT

  • Deegan CA, Murray D, Doran P, Ecimovic P, Moriarty DC, Buggy DJ. Effect of anaesthetic technique on oestrogen receptor-negative breast cancer cell function in vitro. Br J Anaesth. 2009 Nov;103(5):685-90. doi: 10.1093/bja/aep261. Epub 2009 Sep 22.

    PMID: 19776028RESULT

  • Boughey JC, Goravanchi F, Parris RN, Kee SS, Kowalski AM, Frenzel JC, Bedrosian I, Meric-Bernstam F, Hunt KK, Ames FC, Kuerer HM, Lucci A. Prospective randomized trial of paravertebral block for patients undergoing breast cancer surgery. Am J Surg. 2009 Nov;198(5):720-5. doi: 10.1016/j.amjsurg.2008.11.043. Epub 2009 May 9.

    PMID: 19427625RESULT

  • Goldfarb Y, Ben-Eliyahu S. Surgery as a risk factor for breast cancer recurrence and metastasis: mediating mechanisms and clinical prophylactic approaches. Breast Dis. 2006-2007;26:99-114. doi: 10.3233/bd-2007-26109.

    PMID: 17473369RESULT

  • Coveney E, Weltz CR, Greengrass R, Iglehart JD, Leight GS, Steele SM, Lyerly HK. Use of paravertebral block anesthesia in the surgical management of breast cancer: experience in 156 cases. Ann Surg. 1998 Apr;227(4):496-501. doi: 10.1097/00000658-199804000-00008.

    PMID: 9563536RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Kristie Osteen, MD

    Ochsner Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristie Osteen, MD

CONTACT

504-842-3755kosteen@ochsner.org

Heather S Porter, BA

CONTACT

504-842-4812hporter@ochsner.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Perioperative Anesthesia

Study Record Dates

First Submitted

October 7, 2010

First Posted

October 8, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

March 21, 2014

Record last verified: 2014-03

Locations

US(1)