Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003000
Status:
COMPLETED
Last Update Posted:
2015-10-14
First Post:
1999-11-01
Brief Title:
Morphine for the Treatment of Pain in Patients With Breast Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection
Status:
COMPLETED
Status Verified Date:
2015-10
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 Morphine helps to relieve the pain associated with cancer surgery Giving morphine in different ways may offer more pain relief
PURPOSE This randomized clinical trial is studying how well morphine injected directly into the underarm area works compared with morphine injected into the back of the shoulder in treating pain in patients who have breast cancer and who are undergoing axillary lymph node dissection
PURPOSE This randomized clinical trial is studying how well morphine injected directly into the underarm area works compared with morphine injected into the back of the shoulder in treating pain in patients who have breast cancer and who are undergoing axillary lymph node dissection
Detailed Description:
OBJECTIVES I Determine whether morphine injected at the site of surgery can control pain from surgery
OUTLINE This is a prospective double blind randomized study Patients are randomized into 3 groups with 6 patients in each group Group 1 receives morphine diluted in normal saline NS which is administered in the axillary region at the completion of surgery before surgical closure The area is flooded and the solution is allowed to remain in the wound for 5 minutes Group 2 control group receives NS only administered in the same fashion as group 1 Group 3 receives morphine subcutaneously in the deltoid area ipsilateral to the site of surgery at the beginning of wound closure Postoperatively patients self-administer IV fentanyl analgesia through a patient controlled analgesia pump Comparisons of daily IV fentanyl utilization is done among the three groups Quality of pain is assessed via visual analog pain scores four times a day at 2 4 6 and 24 hours postoperatively
PROJECTED ACCRUAL A total of 18 patients will be accrued over a period of 2 years
OUTLINE This is a prospective double blind randomized study Patients are randomized into 3 groups with 6 patients in each group Group 1 receives morphine diluted in normal saline NS which is administered in the axillary region at the completion of surgery before surgical closure The area is flooded and the solution is allowed to remain in the wound for 5 minutes Group 2 control group receives NS only administered in the same fashion as group 1 Group 3 receives morphine subcutaneously in the deltoid area ipsilateral to the site of surgery at the beginning of wound closure Postoperatively patients self-administer IV fentanyl analgesia through a patient controlled analgesia pump Comparisons of daily IV fentanyl utilization is done among the three groups Quality of pain is assessed via visual analog pain scores four times a day at 2 4 6 and 24 hours postoperatively
PROJECTED ACCRUAL A total of 18 patients will be accrued over a period of 2 years
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-92-13 | None | None | None |