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Randomized Study of the Peripheral Effects of Opioid Analgesia in Patients with Breast Cancer Undergoing Axillary Node Dissection (Summary Last Modified 07/2000)

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

Morphine for the Treatment of Pain in Patients With Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
No phase specified Natural history/Epidemiology Closed no age specified Other RPCI-DS-92-13
NCI-V97-1251, NCT00003000

Objectives


I.  Determine whether morphine injected at the site of surgery can control 
pain from surgery.

Entry Criteria

Disease Characteristics:


Patients with breast cancer who are scheduled to undergo axillary node
 dissection

Prior/Concurrent Therapy:


No oral-equivalent doses of morphine greater than 10 mg a day

-- Patient Characteristics--

Age:
 Not specified   

Sex:
 Not specified   

Other:
 Not allergic to morphine

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:


--Disease Characteristics--

Patients with breast cancer who are scheduled to undergo axillary node
 dissection

--Prior/Concurrent Therapy--

No oral-equivalent doses of morphine greater than 10 mg a day

-- Patient Characteristics--

Age:
 Not specified   

Sex:
 Not specified   

Other:
 Not allergic to morphine

Expected Enrollment

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.

Trial Contact Information

Trial Lead Organizations

Roswell Park Cancer Institute

Anthony T. Yarussi, MD, Protocol chair
Ph: 716-845-8630; 800-685-6825

Registry Information

Official Title		Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection

Trial Start Date		1992-05-12

Registered in ClinicalTrials.gov		NCT00003000

Date Submitted to PDQ		1992-05-12

Information Last Verified		2007-05-14

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.