Ultrasound vs. Predetermined Distance Techniques for Paravertebral Nerve Block in Patients Having Breast Surgery

NCT ID: NCT01217593

Last Updated: 2014-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Mastectomy Breast Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ultrasound

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

Group Type EXPERIMENTAL

ultrasound

Intervention Type PROCEDURE

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

predetermined distance

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

Group Type ACTIVE_COMPARATOR

predetermined distance

Intervention Type PROCEDURE

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

Interventions

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ultrasound

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

Intervention Type PROCEDURE

predetermined distance

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

25 Years

Maximum Eligible Age

85 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ochsner Health System

OTHER

Sponsor Role lead

Responsible Party

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Kristie Osteen

Director of Perioperative Anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristie Osteen, MD

Role: PRINCIPAL_INVESTIGATOR

Ochsner Health System

Locations

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Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kristie Osteen, MD

Role: CONTACT

504-842-3755

Heather S Porter, BA

Role: CONTACT

504-842-4812

Facility Contacts

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Kristie Osteen, MD

Role: primary

504-842-3755

Heather Porter, BA

Role: backup

504-842-4812

References

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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.

Reference Type BACKGROUND
PMID: 708565 (View on PubMed)

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.

Reference Type RESULT
PMID: 9322469 (View on PubMed)

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.

Reference Type RESULT
PMID: 17456685 (View on PubMed)

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.

Reference Type RESULT
PMID: 15923270 (View on PubMed)

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.

Reference Type RESULT
PMID: 17449890 (View on PubMed)

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.

Reference Type RESULT
PMID: 19776028 (View on PubMed)

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.

Reference Type RESULT
PMID: 19427625 (View on PubMed)

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.

Reference Type RESULT
PMID: 17473369 (View on PubMed)

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.

Reference Type RESULT
PMID: 9563536 (View on PubMed)

Other Identifiers

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PI-Osteen

Identifier Type: OTHER

Identifier Source: secondary_id

2010.116.C

Identifier Type: -

Identifier Source: org_study_id

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