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Epidural Hydromorphone Compared With Hydromorphone Infusion in Treating Patients With Prostate Cancer Undergoing Radical Prostatectomy

Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain; Prostate Cancer

Intervention: hydromorphone hydrochloride (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Roswell Park Cancer Institute

Official(s) and/or principal investigator(s):
Robert P. Sands, MD, Study Chair, Affiliation: Roswell Park Cancer Institute

Summary

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.

Clinical Details

Official title: Spinal Effects of Epidural Hydromorphone

Study design: Supportive Care

Detailed description: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Male.

Criteria:

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
Additional Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Starting date: June 1996
Last updated: May 23, 2008

Page last updated: June 20, 2008

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