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

Prostate Cancer Clinical Trial

Official title:

Spinal Effects of Epidural Hydromorphone

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003115
• Other study ID #: CDR0000065866
• Secondary ID: RPCI-DS-95-35
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: February 22, 2011
• Start date: June 1996
• Est. completion date: February 2004

Study information

• Verified date: February 2011
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 2004
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pain
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• hydromorphone hydrochloride

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States,