An interventional study of Epidural and Paravertebral catheters in Acute Pain, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-08-31.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
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:
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:
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.
908 studies on the registry are indexed under Acute Pain; 154 are open to participants now.
This study's enrollment of 50 is below the median of 87 across 759 interventional studies indexed under Acute Pain.
Browse Acute Pain studies →University of Minnesota is the lead sponsor of 1,210 studies on the registry; 195 are open to participants now.
Of its 133 completed or terminated interventional studies of FDA-regulated products, 92 (69%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Previous difficult airway or multiple previous intubations
Contraindication to regional anesthesia
Epidural placed for postoperative pain control
Procedure: Epidural
Bilateral paravertebral catheters placed for postoperative pain control
Procedure: Paravertebral catheters
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
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
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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