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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00538499
First received: October 1, 2007
Last updated: December 4, 2012
Last verified: December 2012

October 1, 2007
December 4, 2012
October 2004
April 2008   (final data collection date for primary outcome measure)
Overall consumption of narcotics between the 3 treatment arms [ Time Frame: up to 24 hours after surgery ] [ Designated as safety issue: No ]
Overall consumption of narcotics between the 3 treatment arms
Complete list of historical versions of study NCT00538499 on ClinicalTrials.gov Archive Site
  • Differences in Visual Analog Scale measurements between the 3 treatment arms [ Time Frame: baseline and 6, 12, 18, and 24 hours post-surgery ] [ Designated as safety issue: No ]
  • Rates of conversion and overall satisfaction with pain management [ Time Frame: 24 hours post-surgery ] [ Designated as safety issue: No ]
  • Differences in Visual Analog Scale measurements between the 3 treatment arms
  • Rates of conversion and overall satisfaction with pain management
Not Provided
Not Provided
 
Fentanyl With or Without Bupivacaine in Reducing Pain in Patients Undergoing Video-Assisted Chest Surgery
Optimal Pain Management After Video-Assisted Thoracic Surgery

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pain
  • Perioperative/Postoperative Complications
  • Drug: Fentanyl citrate
  • Drug: Bupivacaine hydrocloride
  • Procedure: videothoracoscopy
  • Fentanyl citrate
    Intervention: Drug: Fentanyl citrate
  • Experimental: bupivcaine hydrochloride
    Intervention: Drug: Bupivacaine hydrocloride
  • videothoracoscopy
    Intervention: Procedure: videothoracoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2009
April 2008   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00538499
CDR0000565803, RPCI-I-37404
Yes
Roswell Park Cancer Institute
Roswell Park Cancer Institute
Not Provided
Principal Investigator: Todd L. Demmy, MD Roswell Park Cancer Institute
Roswell Park Cancer Institute
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP