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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
A mid thoracic epidural is placed preoperatively and a local anesthetic and opioid infusion is run postoperatively
Bilateral paravertebral catheters are placed and a local anesthetic infusion via an elastomeric pump is run postoperatively
University of Minnesota
Minneapolis, Minnesota, United States
total Maximal Pain scored via NRS 0-10 scale
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Time frame: on postoperative day 1 through postoperative day 5
Maximal Pain scored via NRS 0-10 scale
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Time frame: on postoperative day 1
Maximal Pain scored via NRS 0-10 scale
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Time frame: on postoperative day 2
Maximal Pain scored via NRS 0-10 scale
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Time frame: on postoperative day 3
Maximal Pain scored via NRS 0-10 scale
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Time frame: on postoperative day 4
Maximal Pain scored via NRS 0-10 scale
maximal pain scored via NRS 0-10 scale assessed by independent assessor
Time frame: on postoperative day 5
Nausea/vomiting
the presence of nausea and or vomiting endorsed by the patient as assessed by an independent assessor
Time frame: the first five days postoperatively
Length of stay
up through the time the patient is discharged , expected length of stay 10 days.
Time frame: when the patient meets discharge criteria or is discharged home, expected length of stay 10 days
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