Fentanyl With or Without Bupivacaine in Reducing Pain in Patients Undergoing Video-Assisted Chest Surgery
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|ClinicalTrials.gov Identifier: NCT00538499|
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : February 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Pain Perioperative/Postoperative Complications||Drug: Fentanyl citrate Drug: Bupivacaine hydrocloride Procedure: videothoracoscopy||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimal Pain Management After Video-Assisted Thoracic Surgery|
|Actual Study Start Date :||October 28, 2004|
|Actual Primary Completion Date :||July 27, 2007|
|Actual Study Completion Date :||September 2009|
|Fentanyl citrate||Drug: Fentanyl citrate|
|Experimental: bupivcaine hydrochloride||Drug: Bupivacaine hydrocloride|
- Overall consumption of narcotics between the 3 treatment arms [ Time Frame: up to 24 hours after surgery ]
- Differences in Visual Analog Scale measurements between the 3 treatment arms [ Time Frame: baseline and 6, 12, 18, and 24 hours post-surgery ]
- Rates of conversion and overall satisfaction with pain management [ Time Frame: 24 hours post-surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|