Epidural Hydromorphone Compared With Hydromorphone Infusion in Treating Patients With Prostate Cancer Undergoing Radical Prostatectomy
Information source: Roswell Park Cancer Institute
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Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Prostate Cancer
Intervention: hydromorphone hydrochloride (Drug)
Phase: Phase 3
Sponsored by: Roswell Park Cancer Institute
RATIONALE: Giving hydromorphone in different ways may relieve the pain associated with
PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of epidural
hydromorphone with hydromorphone infusion in patients with prostate cancer undergoing
Official title: Spinal Effects of Epidural Hydromorphone
Study design: Primary Purpose: Supportive Care
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
Minimum age: 18 Years.
Maximum age: 70 Years.
DISEASE CHARACTERISTICS: Histologically confirmed prostate cancer Not metastatic Must be
undergoing radical prostatectomy
PATIENT CHARACTERISTICS: Age: 18-70 Performance status: Not specified Life expectancy: Not
specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified
Neurologic: No presence of an intracranial lesion associated with increased intracranial
pressure Pulmonary: No chronic obstructive pulmonary disease No cor pulmonale No emphysema
No kyphoscoliosis No status asthmaticus Other: No contraindications for the insertion of
epidural catheter No known hypersensitivity to hydromorphone No history of alcoholism,
drug abuse, mental dysfunction, or cognitive deficiencies
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified
Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified for
prior surgery(ies) Other: No preoperative opioids for any reason
Locations and Contacts
Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 1996
Last updated: February 22, 2011