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| ID | Type | Description | Link |
|---|---|---|---|
| RPCI-I-37404 |
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RATIONALE: Patient-controlled analgesia using fentanyl and bupivacaine may lessen pain caused by video-assisted chest surgery. Giving bupivacaine in different ways may give better pain relief.
PURPOSE: Thisrandomized clinical trial is comparing three different ways to give bupivacaine together with fentanyl to see how well they work in reducing pain after video-assisted chest surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
In all arms, visual analog scale measurements are taken at baseline and 6, 12, 18, and 24 hours post-surgery. After 24 hours, a 5-point Likert scale survey is administered to assess overall patient satisfaction with pain control in the 24-hour postoperative period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl citrate | Other |
| |
| bupivcaine hydrochloride | Experimental |
| |
| videothoracoscopy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl citrate | Drug |
| ||
| Bupivacaine hydrocloride |
| Measure | Description | Time Frame |
|---|---|---|
| Overall consumption of narcotics between the 3 treatment arms | up to 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in Visual Analog Scale measurements between the 3 treatment arms | baseline and 6, 12, 18, and 24 hours post-surgery | |
| Rates of conversion and overall satisfaction with pain management | 24 hours post-surgery |
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DISEASE CHARACTERISTICS:
Candidate for video-assisted thoracic surgery (VATS) and unlikely to require conversion to open thoracotomy as determined by physician
Able to satisfactorily complete a Visual Analog Scale (VAS) measurement
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Todd L. Demmy, MD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D020775 | Thoracic Surgery, Video-Assisted |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013906 | Thoracoscopy |
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|
| videothoracoscopy | Procedure |
|
| D004724 |
| Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D020535 | Video-Assisted Surgery |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |