Paravertebral Catheters for Pancreatic Surgery
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Epidural; Paravertebral catheters
Intervention type(s): Procedure; Procedure
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment