Fentanyl With or Without Bupivacaine in Reducing Pain in Patients Undergoing Video-Assisted Chest Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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OBJECTIVES: Primary To compare the efficacy of intravenous, patient-controlled, narcotic pain management alone to the efficacy of intermittent bolus injection of bupivacaine hydrochloride via an intrapleural catheter in patients who have successfully undergone video-assisted thoracic surgery (VATS). Secondary To compare the efficacy of intermittent bolus administration of bupivacaine hydrochloride to the efficacy of continuous bupivacaine hydrochloride administration via an intrapleural catheter in patients who have successfully undergone VATS. To compare visual analog scale pain scores at all measurement times. To compare patient satisfaction scores for each method of pain control. To compare rates of conversion from bolus delivery to intravenous narcotic delivery. To compare rates of conversion from continuous intrapleural infusion to bolus delivery or intravenous narcotic delivery alone. To compare the total amount of narcotics used between bolus intrapleural delivery and continuous intrapleural infusion. OUTLINE: Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive intravenous patient-controlled analgesia (IV-PCA) fentanyl citrate beginning once the patient is awake and alert after surgery and continuing for 24 hours. Arm II: Patients receive intermittent intrapleural bolus bupivacaine hydrochloride immediately after surgery and then at 6, 12, 18, and 24 hours after surgery and IV-PCA fentanyl citrate as in arm I. Arm III: Patients receive a continuous infusion of intrapleural bupivacaine hydrochloride beginning immediately after surgery and continuing for 24 hours and IV-PCA fentanyl citrate as in arm I. 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.

Official Title
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Optimal Pain Management After Video-Assisted Thoracic Surgery

Conditions
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Pain, Perioperative/Postoperative Complications

Intervention / Treatment
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* Drug: Fentanyl citrate
* Drug: Bupivacaine hydrocloride
* Procedure: videothoracoscopy


Participation Criteria
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Eligibility Criteria
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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 Patients who are too sedated postoperatively or who are unable to properly mark a VAS scale due to other factors (poor eyesight, lack of manual dexterity, or lack of comprehension of the test) are ineligible PATIENT CHARACTERISTICS: No allergy to bupivacaine hydrochloride or fentanyl citrate No known renal or liver disease (i.e., hepatic insufficiency or cirrhosis) that would affect metabolism of drugs used in this study Not pregnant or nursing Negative pregnancy test No thoracic infection within the past 3 months Weight ≥ 55 kg ALT and AST < 10% of upper limit of normal Serum creatinine < 1.5 mg/dL BUN < 40 mg/dL PRIOR CONCURRENT THERAPY: No concurrent narcotics for pain management No concurrent amiodarone, barbiturate anesthetics or other CNS depressants, diazepam, droperidol, nitrous oxide, or protease inhibitors

Ages Eligible for Study
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Maximum Age: 120 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Fentanyl citrate<br> | Drug: Fentanyl citrate<br> <br> |
| Experimental: bupivcaine hydrochloride<br> | Drug: Bupivacaine hydrocloride<br> <br> |
| Other: videothoracoscopy<br> | Procedure: videothoracoscopy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall consumption of narcotics between the 3 treatment arms |  | up to 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, perioperative/postoperative complications