Paravertebral Catheters for Pancreatic Surgery

Completed · Not applicable

Conditions studied: Acute Pain

In brief

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.

Key facts

Study ID

NCT02363777

Run by

University of Minnesota

People needed

50

Starts

2012-08-01

Expected to finish

2016-06-01

Last updated by the study team

2017-08-31

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • All patients undergoing open pancreatic surgery.

You may not qualify if…

• • 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;

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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