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

Pain Clinical Trial

Official title: Optimal Pain Management After Video-Assisted Thoracic Surgery

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Pain
• Perioperative/Postoperative Complications
• Postoperative Complications

• NCT number: NCT00538499
• Study type: Interventional
• Source: Roswell Park Cancer Institute
• Status: Completed
• Phase: N/A
• Start date: October 28, 2004
• Completion date: September 2009