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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | Epidural placed for postoperative pain control |
|
| Experimental Intervention | Experimental | Bilateral paravertebral catheters placed for postoperative pain control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural | Procedure | A mid thoracic epidural is placed preoperatively and a local anesthetic and opioid infusion is run postoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Pain scored via NRS 0-10 scale | maximal pain scored via NRS 0-10 scale assessed by independent assessor | on postoperative day 1 |
| Maximal Pain scored via NRS 0-10 scale | maximal pain scored via NRS 0-10 scale assessed by independent assessor |
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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 or chronic pain syndrome
Lack of patient cooperation
Contraindication to regional anesthesia
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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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 |
|---|---|
| D007268 | Injections, Epidural |
| ID | Term |
|---|---|
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
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| Paravertebral catheters | Procedure | Bilateral paravertebral catheters are placed and a local anesthetic infusion via an elastomeric pump is run postoperatively |
|
| on postoperative day 2 |
| Maximal Pain scored via NRS 0-10 scale | maximal pain scored via NRS 0-10 scale assessed by independent assessor | on postoperative day 3 |
| Maximal Pain scored via NRS 0-10 scale | maximal pain scored via NRS 0-10 scale assessed by independent assessor | on postoperative day 4 |
| Maximal Pain scored via NRS 0-10 scale | maximal pain scored via NRS 0-10 scale assessed by independent assessor | on postoperative day 5 |
| Nausea/vomiting | the presence of nausea and or vomiting endorsed by the patient as assessed by an independent assessor | the first five days postoperatively |
| 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 |
| D013812 |
| Therapeutics |