Acute Pain Clinical Trial
Official title:
Ultrasound Guided Bilateral Paravertebral Catheters Versus Thoracic Epidural Analgesia for Post- Operative Pain Control in Open Pancreatic Surgery: A Prospective Outcomes Study
Verified date | August 2017 |
Source | University of Minnesota - Clinical and Translational Science Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | June 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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; |
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | total Maximal Pain scored via NRS 0-10 scale | maximal pain scored via NRS 0-10 scale assessed by independent assessor | on postoperative day 1 through postoperative day 5 | |
Secondary | Maximal Pain scored via NRS 0-10 scale | maximal pain scored via NRS 0-10 scale assessed by independent assessor | on postoperative day 1 | |
Secondary | Maximal Pain scored via NRS 0-10 scale | maximal pain scored via NRS 0-10 scale assessed by independent assessor | on postoperative day 2 | |
Secondary | Maximal Pain scored via NRS 0-10 scale | maximal pain scored via NRS 0-10 scale assessed by independent assessor | on postoperative day 3 | |
Secondary | Maximal Pain scored via NRS 0-10 scale | maximal pain scored via NRS 0-10 scale assessed by independent assessor | on postoperative day 4 | |
Secondary | Maximal Pain scored via NRS 0-10 scale | maximal pain scored via NRS 0-10 scale assessed by independent assessor | on postoperative day 5 | |
Secondary | Nausea/vomiting | the presence of nausea and or vomiting endorsed by the patient as assessed by an independent assessor | the first five days postoperatively | |
Secondary | Length of stay | up through the time the patient is discharged , expected length of stay 10 days. | when the patient meets discharge criteria or is discharged home, expected length of stay 10 days |
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