Acute Pain Clinical Trial
Official title:
Ultrasound Guided Bilateral Paravertebral Catheters Versus Thoracic Epidural Analgesia for Post- Operative Pain Control in Open Pancreatic Surgery: A Prospective Outcomes Study
Design: Level I randomized prospective outcomes study comparing two groups of patients. One
group will receive bupivacaine and dilaudid thoracic epidural analgesia (PCA)
post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks
with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively
and a PCA.
Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients
presenting to the University of Minnesota Medical Center for elective open pancreatic
surgery.
Primary Objective: To determine if bilateral paravertebral catheters in patients with open
pancreatic procedures result in decreased pain compared to patients treated with thoracic
epidural for post-operative pain.
Secondary Objectives:
1. To determine whether the use of bilateral paravertebral catheters impacts the length of
ICU and hospital stay for patients, compared to a thoracic epidurals in patients
undergoing elective open pancreatic surgery.
2. To determine whether the use of ultrasound guided bilateral paravertebral catheters
leads to lower risk of complications, compared to use of a thoracic epidural in patients
undergoing open pancreatic surgery.
Design: Level I randomized prospective outcomes study comparing two groups of patients. One
group will receive buipvacanine and dilaudid thoracic epidural analgesia (PCA)
post-operatively. The other will receive bilateral ultrasound guided paravertebral blocks
with indwelling paravertebral catheters with an infusion of 0.2% ropivicaine post-operatively
and a PCA.
Sample Size: 50 patients Study Duration: Approximately 12 months Population:. Patients
presenting to the University of Minnesota Medical Center for elective open pancreatic
surgery.
Primary Objective: To determine if bilateral paravertebral catheters in patients with open
pancreatic procedures result in decreased total maximal pain scores compared to patients
treated with thoracic epidural for post-operative pain.
Secondary Objectives:
1. To determine whether the use of bilateral paravertebral catheters impacts the length of
ICU and hospital stay for patients, compared to a thoracic epidurals in patients
undergoing elective open pancreatic surgery.
2. To determine whether the use of ultrasound guided bilateral paravertebral catheters
leads to lower risk of complications, compared to use of a thoracic epidural in patients
undergoing open pancreatic surgery.
2. Synopsis and Medical Application:
Specific Aims:
Primary Hypothesis: Paravertebral catheters will result in improved pain control relative to
thoracic epidural for post-operative pain from open pancreatic surgery.
Secondary Hypothesis: Paravertebral catheters will result in fewer hospital days and improved
subjective respiratory function compared to patients in the thoracic epidural group.
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