Spinal Effects of Epidural Hydromorphone
OBJECTIVES: I. Define the duration of action of hydromorphone (spinal vs supraspinal) in
patients who have undergone radical prostatectomy. II. Demonstrate that the duration of the
analgesic effects of equal blood concentrations of hydromorphone is dependent on the method
used to attain this concentration by comparing continuous epidural infusion with that of a
continuous intravenous infusion.
OUTLINE: This is a double blinded, randomized study. After all patients have undergone
radical prostatectomy, hydromorphone is administered in two different ways. Patients receive
either a hydromorphone bolus injection through an epidural catheter using a patient
controlled analgesia pump or a hydromorphone bolus injection through an intravenous catheter
using a patient controlled analgesia pump. Infusion for both groups is stopped at 24 hours.
Patients are followed every 30 minutes for 6 hours.
PROJECTED ACCRUAL: A total of 40 patients will be accrued into this study over a 3 year
period.
Interventional
Primary Purpose: Supportive Care
United States: Food and Drug Administration
CDR0000065866
NCT00003115
June 1996
February 2004
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |