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	Treatment or Intervention	Phase
Pain Prostate Cancer	Drug: hydromorphone	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years   -   70 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed prostate cancer
• Not metastatic
• Must be undergoing radical prostatectomy

--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

--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

New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

Study chairs or principal investigators

Robert P. Sands, Jr.,  Study Chair,  Roswell Park Cancer Institute   

Study ID Numbers:  CDR0000065866; RPCI-DS-95-35; NCI-G97-1352
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003115
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08