Epidural Hydromorphone Compared With Hydromorphone Infusion in Treating Patients With Prostate Cancer Undergoing Radical Prostatectomy
NCT ID: NCT00003115
Last Updated: 2011-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
40 participants
INTERVENTIONAL
1996-06-30
2004-02-29
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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SUPPORTIVE_CARE
Interventions
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hydromorphone hydrochloride
Eligibility Criteria
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Inclusion Criteria
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
18 Years
70 Years
MALE
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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RPCI-DS-95-35
Identifier Type: -
Identifier Source: secondary_id
CDR0000065866
Identifier Type: -
Identifier Source: org_study_id
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