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

This study has been completed.
Information provided by (Responsible Party):
Roswell Park Cancer Institute Identifier:
First received: October 1, 2007
Last updated: February 8, 2017
Last verified: February 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 Intervention
Pain Perioperative/Postoperative Complications Drug: Fentanyl citrate Drug: Bupivacaine hydrocloride Procedure: videothoracoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Optimal Pain Management After Video-Assisted Thoracic Surgery

Resource links provided by NLM:

Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Overall consumption of narcotics between the 3 treatment arms [ Time Frame: up to 24 hours after surgery ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 30
Actual Study Start Date: October 28, 2004
Study Completion Date: September 2009
Primary Completion Date: July 27, 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fentanyl citrate Drug: Fentanyl citrate
Experimental: bupivcaine hydrochloride Drug: Bupivacaine hydrocloride
videothoracoscopy Procedure: videothoracoscopy

Detailed Description:



  • 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.


Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • No concurrent narcotics for pain management
  • No concurrent amiodarone, barbiturate anesthetics or other CNS depressants, diazepam, droperidol, nitrous oxide, or protease inhibitors
  Contacts and Locations
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Please refer to this study by its identifier: NCT00538499

United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
Principal Investigator: Todd L. Demmy, MD Roswell Park Cancer Institute
  More Information

Responsible Party: Roswell Park Cancer Institute Identifier: NCT00538499     History of Changes
Other Study ID Numbers: CDR0000565803
Study First Received: October 1, 2007
Last Updated: February 8, 2017

Keywords provided by Roswell Park Cancer Institute:
perioperative/postoperative complications

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes
Citric Acid
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Opioid
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action processed this record on July 19, 2017