Ignite Creation Date:
2024-05-05 @ 1:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003115
Status:
COMPLETED
Last Update Posted:
2011-02-23
First Post:
1999-11-01
Brief Title:
Epidural Hydromorphone Compared With Hydromorphone Infusion in Treating Patients With Prostate Cancer Undergoing Radical Prostatectomy
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Spinal Effects of Epidural Hydromorphone
Status:
COMPLETED
Status Verified Date:
2011-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RPCI-DS-95-35 | None | None | None |