Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| No phase specified | Supportive care | Completed | Not specified | Other | CDR0000065555 RPCI-DS-92-13, NCI-V97-1251, NCT00003000 |
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.
Further Study Information
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.
Eligibility 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
Trial Lead Organizations/Sponsors
Roswell Park Cancer Institute
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00003000
Information obtained from ClinicalTrials.gov on February 05, 2012
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