Paravertebral Catheters for Pancreatic Surgery



Status:Completed
Conditions:Chronic Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - 85
Updated:9/1/2017
Start Date:August 2012
End Date:June 2016

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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.

Inclusion Criteria:

- • All patients undergoing open pancreatic surgery.

Exclusion Criteria:

- • Previous difficult airway or multiple previous intubations

- History of myasthenic syndrome

- Systemic infection

- Pre-existing sensory deficit

- PT >14 or PTT >40 sec

- Platelet count less than 50,000

- Creatinine > 1.5

- Allergy to local anesthetics

- Patients who remain intubated for one week after surgery or who are unable to
provide information as to their feelings of pain post-operatively for the first
week post-operatively

- Use of a spinal or epidural anesthetic for surgery

- Daily use of opioid for more than a week or chronic pain syndrome

- Lack of patient cooperation

- Contraindication to regional anesthesia

- Infection at injection site

- Inability to guarantee sterile equipment or sterile conditions for the block

- Patient refusal

- Risk of local anesthetic toxicity

- Coagulopathy or bleeding disorder

- Severe respiratory disease (where the patient depends on intercostal muscle
function for ventilation);

- Ipsilateral diaphragmatic paresis;
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Phone: 612-624-9990
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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