Paravertebral Catheters for VATS Procedures

Study Overview
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Brief Summary
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Level I randomized prospective outcomes study comparing two groups of patients. One group will receive Dilaudid patient controlled analgesia (PCA) post-operatively. The other will receive an ultrasound guided paravertebral block with indwelling paravertebral catheter with an infusion of 0.2% Ropivicaine post-operatively and a PCA.

Detailed Description
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Design: Level I randomized prospective outcomes study comparing two groups of patients. One group will receive Dilaudid patient controlled analgesia (PCA) post-operatively. The other will receive an ultrasound guided paravertebral block with indwelling paravertebral catheter with an infusion of 0.2% Ropivicaine post-operatively and a PCA. Sample Size: 50 patients Study Duration: Approximately 24 months Population:. Patients presenting to the University of Minnesota Medical Center for elective Video Assisted Thoracoscopic Surgery (VATS), for thoracic, lung, or mediastinal lesions or masses. Primary Objective: To determine if post-operative paravertebral catheters in patients with elective VATS procedures result in decreased pain compared to patients treated with PCA for post-operative pain. Secondary Objectives: To determine whether the use of paravertebral catheters impacts the length of ICU and hospital stay for patients, compared to a PCA in patients undergoing elective Video Assisted Thoracoscopic Surgery (VATS). To determine whether the use of paravertebral catheters leads to lower risk of complications, compared to use of a PCA in patients undergoing elective Video Assisted Thoracoscopic Surgery (VATS). 2. Synopsis and Medical Application: Specific Aims: Primary Hypothesis: Paravertebral catheters will result in improved pain control relative to PCA for post-operative pain from thoracic surgery. Secondary Hypothesis: Paravertebral catheters will result in fewer hospital days and improved subjective respiratory function compared to patients in the PCA group.

Official Title
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Ultrasound Guided Paravertebral Catheter Versus Patient Controlled Analgesia for Postoperative Pain Control in Video Assisted Thoracoscopic Surgery: A Prospective Outcomes Study

Conditions
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Acute Pain

Intervention / Treatment
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* Device: Paravertebral catheter
* Device: opioid iv pca
* Drug: Ropivacaine
* Device: Elastomeric Pump


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • All patients undergoing elective VATS. 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 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; Severe spinal deformities (kyphosis or scoliosis) Previous thoracotomy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Paravertebral catheter<br>a paravertebral catheter is placed and an elastomeric pump is connected to infuse 0.2% ropivacaine postoperatively | Device: Paravertebral catheter<br>* A catheter is placed ultrasound guided at the T5 paravertebral level<br>Drug: Ropivacaine<br>* 0.2% ropivacaine infused through paravertebral catheter<br>* Other names: Naropin;Device: Elastomeric Pump<br>* Elastomeric pump connected to paravertebral catheter<br>* Other names: On Q;|
| Active Comparator: IV PCA<br>opioid PCA consisting of hydromorphone is connected to patient in the post anesthesia care unit | Device: opioid iv pca<br>* opioid pca consisting of hydromorphone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum NRS Pain score | pain at movement or maximum in first 24 hours after surgery | 0-24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total opioid use | total opioids converted to morphine equivalents | the first 5 days after surgery | 
| length of stay | participants will be followed for duration of stay expected 5 days | time until patient is ready to be discharged or is discharged, expected 5 days |