Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Proposal Log Number 04070001 | |||
| Award Number W81XWH-05-1-0047 |
Not provided
Not provided
inadequate sample population
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Henry M. Jackson Foundation for the Advancement of Military Medicine | OTHER |
| U.S. Army Medical Research and Development Command | FED |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare:
following Video Assisted Thorascopic Surgery (VATS) performed under general anesthesia with the addition of intra-operative single-injection paravertebral blockade vs general anesthesia with a sham intra-operative paravertebral nerve blockade
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Patients randomized to receive thoracic paravertebral nerve blockade in addition to general endotracheal anesthesia during video assisted thoracoscopy procedure |
|
| B | Sham Comparator | Patients randomized to receive sham single-injection thoracic peripheral nerve blockade (no injection) in addition to general endotracheal anesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thoracic Paravertebral Nerve Block | Procedure | One Single-injection, thoracic peripheral nerve blockade performed intraoperatively following patient induction with general endotracheal anesthesia |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the degree of systemic post-operative inflammation with the degree of post-operative pain | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the degree of pain and nausea | 1 year |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Age less than 18
Clinical or laboratory evidence of systemic infection
Current pregnancy as assessed by preoperative urine HCG test
Serious, uncontrolled, non-malignant illness
Malignant illness requiring systemic chemotherapy in the last 6 months
Documented allergy to oxycodone, morphine sulfate or acetaminophen
Contraindication to peripheral nerve blockade or general anesthesia including:
Planned pleurodesis
Current use of high dose inhaled or systemic steroids
Current use of Amiodarone (Cordarone)
Morbid obesity (BMI=40kg/m2)
Patients with clinically significant mental health issues such as psychosis requiring treatment with antipsychotic medications.
Patients unable to consent
Patients with active infections requiring antibiotics within one month of registration
Participation in other clinical trials that may interfere with this study
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William T Fritz, MD | Memorial Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Medical Center | Johnstown | Pennsylvania | 15905 | United States |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Thoracic Paravertebral Nerve Block | Procedure | Sham single-injection thoracic peripheral nerve blockade following patient induction with general endotracheal anesthesia |
|