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

• Differences in Visual Analog Scale measurements between the 3 treatment arms [ Time Frame: baseline and 6, 12, 18, and 24 hours post-surgery ] [ Designated as safety issue: No ]
• Rates of conversion and overall satisfaction with pain management [ Time Frame: 24 hours post-surgery ] [ Designated as safety issue: No ]

• Differences in Visual Analog Scale measurements between the 3 treatment arms
• Rates of conversion and overall satisfaction with pain management

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

• 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.

• Pain
• Perioperative/Postoperative Complications

• Drug: Fentanyl citrate
• Drug: Bupivacaine hydrocloride
• Procedure: videothoracoscopy

• Fentanyl citrate
  Intervention: Drug: Fentanyl citrate
• Experimental: bupivcaine hydrochloride
  Intervention: Drug: Bupivacaine hydrocloride
• videothoracoscopy
  Intervention: Procedure: videothoracoscopy

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