Know Cancer

or
forgot password

Spinal Effects of Epidural Hydromorphone


Phase 3
18 Years
70 Years
Not Enrolling
Male
Pain, Prostate Cancer

Thank you

Trial Information

Spinal Effects of Epidural Hydromorphone


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Supportive Care

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000065866

NCT ID:

NCT00003115

Start Date:

June 1996

Completion Date:

February 2004

Related Keywords:

  • Pain
  • Prostate Cancer
  • prostate cancer
  • pain
  • Prostatic Neoplasms

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263