Pain, Perioperative/Postoperative Complications
Conditions
Keywords
pain, perioperative/postoperative complications
Brief summary
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
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.
Interventions
Sponsors
Roswell Park Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 120 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall consumption of narcotics between the 3 treatment arms | up to 24 hours after surgery |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed