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

Sponsors and Collaborators:	Roswell Park Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00538499

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
Cancer-Related Problem/Condition Pain	Drug: bupivacaine hydrochloride Drug: fentanyl citrate Procedure: videothoracoscopy

MedlinePlus related topics: Cancer

Drug Information available for: Fentanyl Citrate Fentanyl Citric acid Sodium Citrate Bupivacaine Bupivacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized
Official Title:	Optimal Pain Management After Video-Assisted Thoracic Surgery

Further study details as provided by National Cancer Institute (NCI):

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

Estimated Enrollment:	30
Study Start Date:	October 2004
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

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

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

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Todd L. Demmy, MD

Roswell Park Cancer Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000565803, RPCI-I-37404
Study First Received:	October 1, 2007
Last Updated:	December 6, 2008
ClinicalTrials.gov Identifier:	NCT00538499
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

pain
perioperative/postoperative complications

Study placed in the following topic categories:

Fentanyl
Postoperative Complications
Citric Acid
Bupivacaine
Pain

Additional relevant MeSH terms:

Anesthetics, Intravenous
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Narcotics
Anesthetics, Local
Pharmacologic Actions
Adjuvants, Anesthesia

Anesthetics, General
Sensory System Agents
Therapeutic Uses
Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009