An interventional study of ultrasound and predetermined distance in Mastectomy and Breast Neoplasms, sponsored by Ochsner Health System. Status unknown at 1 site in United States. Open to female participants aged 25 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-03-21.
Sponsored by Ochsner Health System · Not applicable, Interventional, and Supportive care
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 60 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Ochsner Health System is the lead sponsor of 54 studies on the registry; 7 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Local anesthetics Fentanyl Hydromorphone Propofol Midazolam
Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
Procedure: ultrasound
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
Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
The predetermined distance technique will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
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.
Time frame: 24 hours
time, incidence of adverse events and patient satisfaction
The secondary objectives will be 1) time taken to locate the paravertebral space and inject local anesthetic 2) time from injection of local anesthetic to adequate sensory block 3) incidence of adverse events including pneumothorax, high spinal, epidural spread, direct nerve damage, paresthesias, vascular puncture, patient discomfort, respiratory depression, hypoxemia, and prolonged sensory blockade and 4) patient satisfaction.
Time frame: 24 hours
This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Ochsner Health System