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A Comparison Of Ultrasound and Predetermined Distance Techniques For Paravertebral Space Localization In Breast Surgery: A Randomized Prospective Trial


N/A
25 Years
85 Years
Open (Enrolling)
Female
Mastectomy, Breast Neoplasms

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Trial Information

A Comparison Of Ultrasound and Predetermined Distance Techniques For Paravertebral Space Localization In Breast Surgery: A Randomized Prospective Trial


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

24 hours

Safety Issue:

No

Principal Investigator

Kristie Osteen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ochsner Clinic Foundation

Authority:

United States: Institutional Review Board

Study ID:

2010.116.C

NCT ID:

NCT01217593

Start Date:

October 2010

Completion Date:

October 2012

Related Keywords:

  • Mastectomy
  • Breast Neoplasms
  • mastectomy
  • breast cancer
  • breast surgery
  • Breast Neoplasms
  • Neoplasms

Name

Location
Ochsner Clinic Foundation New Orleans, Louisiana  70121