Epidural Hydromorphone Compared With Hydromorphone Infusion in Treating Patients With Prostate Cancer Undergoing Radical Prostatectomy
|ClinicalTrials.gov Identifier: NCT00003115|
Recruitment Status : Completed
First Posted : August 12, 2004
Last Update Posted : February 23, 2011
RATIONALE: Giving hydromorphone in different ways may relieve the pain associated with cancer surgery.
PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of epidural hydromorphone with hydromorphone infusion in patients with prostate cancer undergoing radical prostatectomy.
|Condition or disease||Intervention/treatment||Phase|
|Pain Prostate Cancer||Drug: hydromorphone hydrochloride||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Primary Purpose:||Supportive Care|
|Official Title:||Spinal Effects of Epidural Hydromorphone|
|Study Start Date :||June 1996|
|Actual Primary Completion Date :||January 2003|
|Actual Study Completion Date :||February 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003115
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|