Expired Study
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Buffalo, New York 14263


Purpose:

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.


Study summary:

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.


Criteria:

DISEASE CHARACTERISTICS: Patients with breast cancer who are scheduled to undergo axillary node dissection PATIENT CHARACTERISTICS: See General Eligibility Criteria 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


Study is Available At:


Original ID:

CDR0000065555


NCT ID:

NCT00003000


Secondary ID:

RPCI-DS-92-13


Study Acronym:


Brief Title:

Morphine for the Treatment of Pain in Patients With Breast Cancer


Official Title:

Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

120 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Roswell Park Cancer Institute


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: Pro


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

18


Enrollment Type:

Anticipated


Study Dates

Start Date:May 1992
Completion Date:June 2001
Completion Type:Actual
Primary Completion Date:January 2001
Primary Completion Type:Actual
Verification Date:October 2015
Last Changed Date:October 12, 2015
First Received Date:November 1, 1999

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:fentanyl citrate
Intervention Type:Drug
Name:morphine sulfate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Roswell Park Cancer Institute

Samples and Retentions

Study Population: Breast Cancer Patients
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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