Fentanyl With or Without Bupivacaine in Reducing Pain in Patients Undergoing Video-Assisted Chest Surgery
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.
Drug: Fentanyl citrate
Drug: Bupivacaine hydrocloride
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Optimal Pain Management After Video-Assisted Thoracic Surgery|
- Overall consumption of narcotics between the 3 treatment arms [ Time Frame: up to 24 hours after surgery ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||October 2004|
|Study Completion Date:||September 2009|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
|Fentanyl citrate||Drug: Fentanyl citrate|
|Experimental: bupivcaine hydrochloride||Drug: Bupivacaine hydrocloride|
- 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).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00538499
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Principal Investigator:||Todd L. Demmy, MD||Roswell Park Cancer Institute|