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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paravertebral catheter | Experimental | a paravertebral catheter is placed and an elastomeric pump is connected to infuse 0.2% ropivacaine postoperatively |
|
| IV PCA | Active Comparator | opioid PCA consisting of hydromorphone is connected to patient in the post anesthesia care unit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paravertebral catheter | Device | A catheter is placed ultrasound guided at the T5 paravertebral level |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum NRS Pain score | pain at movement or maximum in first 24 hours after surgery | 0-24 hours after surgery |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| the number of patients with presence of nausea and vomiting | the number of patients who have nausea and or vomiting. | the first 5 days postoperatively |
Inclusion Criteria:
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
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| opioid iv pca | Device | opioid pca consisting of hydromorphone |
|
| Ropivacaine | Drug | 0.2% ropivacaine infused through paravertebral catheter |
|
|
| Elastomeric Pump | Device | Elastomeric pump connected to paravertebral catheter |
|
|
| time until patient is ready to be discharged or is discharged, expected 5 days |
| D000588 |
| Amines |