NCT00538499

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

Optimal Pain Management After Video-Assisted Thoracic Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pain
• Perioperative/Postoperative Complications

Interventions

Type	Name	Description
DRUG	Fentanyl citrate
DRUG	Bupivacaine hydrocloride
PROCEDURE	videothoracoscopy

Timeline

• Start date: 2004-10-28
• Primary completion: 2007-07-27
• Completion: 2009-09-01
• First posted: 2007-10-02
• Last updated: 2017-02-09

Locations

1 site across 1 country: United States