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

Not Applicable

Completed

• Conditions: Perioperative/Postoperative Complications; Pain
• Interventions: Drug: Fentanyl citrate; Procedure: videothoracoscopy; Drug: Bupivacaine hydrocloride

• Registration Number: NCT00538499
• Lead Sponsor: Roswell Park Cancer Institute

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.

Study Timeline

• Study Start: 2004-10-28
• Primary Completion: 2007-07-27
• Study First Submitted: 2007-10-01
• Study First Submitted QC: 2007-10-01
• Study First Posted: 2007-10-02
• Study Completion: 2009-09
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-08
• Last Update Posted: 2017-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fentanyl citrate	Fentanyl citrate	-
videothoracoscopy	videothoracoscopy	-
bupivcaine hydrochloride	Bupivacaine hydrocloride	-

Primary Outcome Measures

Name	Time	Method
Overall consumption of narcotics between the 3 treatment arms	up to 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States