Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Closed 18 and over Other RPCI-DS-93-48 NCI-V97-1252

Objectives

I.  Determine whether the administration of epidural morphine sulfate 60 
minutes before surgical skin incision results in better pain control than the 
adiministration of epidural morphine 60 minutes before skin closure in 
patients undergoing thoracotomies.

II.  Assess patient controlled analgesia requirements for intravenous 
alfentanil hydrochloride for 72 hours after thoracotomies in patients 
receiving epidural morphine before skin incision and before skin closure.

III.  Evaluate the quality of pain control in patients receiving morphine 
following presurgical and postsurgical incision.

IV.  Determine the interval of time between the administration of epidural 
morphine and the first administration of breakthrough alfentanil.

Entry Criteria

Disease Characteristics:

Patients must undergo thoracotomies under general anesthesia with an epidural
catheter for postoperative morphine analgesia

Postoperative patients must be intubated for at least 6 hours and become fully
awake 2 hours following procedure

American Society of Anesthesiologists (ASA) class 1, 2, and 3

Prior/Concurrent Therapy:

Biologic therapy:
 Not specified

Chemotherapy:
 Not specified

Endocrine therapy:
 Not specified

Radiotherapy:
 Not specified

Surgery:
 Not specified

Other:
 No prior preoperative opioids for any reason
 No prior intraoperative opioids for any reason

Patient Characteristics:

Age:
 18 and over

Performance status:
 Not specified

Life expectancy:
 Not specified

Hematopoietic:
 Not specified

Hepatic:
 Not specified

Renal:
 Not specified

Other:
 No history of alcoholism, drug abuse, mental dysfunction, or cognitive
  deficiencies
 No contraindication for the insertion of an epidural catheter

Expected Enrollment

This study will accrue 26 patients for the duration of about 4 years.

Outline

This is a prospective, double blind, randomized study.

Patients receive either IV morphine sulfate or placebo via epidural catheter 
60 minutes before surgical incision or 60 minutes before skin closure.

Once extubation criteria are met, postoperative patients receive self-induced 
injections of alfentanil hydrochloride via an IV patient controlled analgesia 
(IV-PCA) device.  Patients are evaluated every 6 hours for quality of pain 
control at rest and during coughing.  Breakthrough doses of IV-PCA alfentanil 
are titrated as necessary to maintain verbal analog pain scale (VAPS) below 4 
throughout study.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Robert P. Sands, MD, Protocol chair		Ph: 716-845-3572; 800-685-6825