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

Primary Purpose

Pain, Perioperative/Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fentanyl citrate
Bupivacaine hydrocloride
videothoracoscopy
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, perioperative/postoperative complications

Eligibility Criteria

undefined - 120 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Candidate for video-assisted thoracic surgery (VATS) and unlikely to require conversion to open thoracotomy as determined by physician
  • Able to satisfactorily complete a Visual Analog Scale (VAS) measurement

    • Patients who are too sedated postoperatively or who are unable to properly mark a VAS scale due to other factors (poor eyesight, lack of manual dexterity, or lack of comprehension of the test) are ineligible

PATIENT CHARACTERISTICS:

  • No allergy to bupivacaine hydrochloride or fentanyl citrate
  • No known renal or liver disease (i.e., hepatic insufficiency or cirrhosis) that would affect metabolism of drugs used in this study
  • Not pregnant or nursing
  • Negative pregnancy test
  • No thoracic infection within the past 3 months
  • Weight ≥ 55 kg
  • ALT and AST < 10% of upper limit of normal
  • Serum creatinine < 1.5 mg/dL
  • BUN < 40 mg/dL

PRIOR CONCURRENT THERAPY:

  • No concurrent narcotics for pain management
  • No concurrent amiodarone, barbiturate anesthetics or other CNS depressants, diazepam, droperidol, nitrous oxide, or protease inhibitors

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Other

Arm Label

Fentanyl citrate

bupivcaine hydrochloride

videothoracoscopy

Arm Description

Outcomes

Primary Outcome Measures

Overall consumption of narcotics between the 3 treatment arms

Secondary Outcome Measures

Differences in Visual Analog Scale measurements between the 3 treatment arms
Rates of conversion and overall satisfaction with pain management

Full Information

First Posted
October 1, 2007
Last Updated
February 8, 2017
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00538499
Brief Title
Fentanyl With or Without Bupivacaine in Reducing Pain in Patients Undergoing Video-Assisted Chest Surgery
Official Title
Optimal Pain Management After Video-Assisted Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 28, 2004 (Actual)
Primary Completion Date
July 27, 2007 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Perioperative/Postoperative Complications
Keywords
pain, perioperative/postoperative complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fentanyl citrate
Arm Type
Other
Arm Title
bupivcaine hydrochloride
Arm Type
Experimental
Arm Title
videothoracoscopy
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Fentanyl citrate
Intervention Type
Drug
Intervention Name(s)
Bupivacaine hydrocloride
Intervention Type
Procedure
Intervention Name(s)
videothoracoscopy
Primary Outcome Measure Information:
Title
Overall consumption of narcotics between the 3 treatment arms
Time Frame
up to 24 hours after surgery
Secondary Outcome Measure Information:
Title
Differences in Visual Analog Scale measurements between the 3 treatment arms
Time Frame
baseline and 6, 12, 18, and 24 hours post-surgery
Title
Rates of conversion and overall satisfaction with pain management
Time Frame
24 hours post-surgery

10. Eligibility

Sex
All
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Candidate for video-assisted thoracic surgery (VATS) and unlikely to require conversion to open thoracotomy as determined by physician Able to satisfactorily complete a Visual Analog Scale (VAS) measurement Patients who are too sedated postoperatively or who are unable to properly mark a VAS scale due to other factors (poor eyesight, lack of manual dexterity, or lack of comprehension of the test) are ineligible PATIENT CHARACTERISTICS: No allergy to bupivacaine hydrochloride or fentanyl citrate No known renal or liver disease (i.e., hepatic insufficiency or cirrhosis) that would affect metabolism of drugs used in this study Not pregnant or nursing Negative pregnancy test No thoracic infection within the past 3 months Weight ≥ 55 kg ALT and AST < 10% of upper limit of normal Serum creatinine < 1.5 mg/dL BUN < 40 mg/dL PRIOR CONCURRENT THERAPY: No concurrent narcotics for pain management No concurrent amiodarone, barbiturate anesthetics or other CNS depressants, diazepam, droperidol, nitrous oxide, or protease inhibitors
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd L. Demmy, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

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

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