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
  Purpose

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: Open Label
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 ] [ Designated as safety issue: No ]

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 ] [ 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 ]

Enrollment: 30
Study Start Date: October 2004
Study Completion Date: September 2009
Primary Completion Date: April 2008 (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:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538499

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

Additional Information:
No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00538499     History of Changes
Other Study ID Numbers: CDR0000565803, RPCI-I-37404
Study First Received: October 1, 2007
Last Updated: December 4, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes
Bupivacaine
Fentanyl
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General

ClinicalTrials.gov processed this record on August 21, 2014