Morphine for the Treatment of Pain in Patients With Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on August 06, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: fentanyl citrate (Drug); morphine sulfate (Drug); pain therapy (Procedure); supportive care/therapy (Procedure)
Status: No longer recruiting
Sponsored by: Roswell Park Cancer Institute Official(s) and/or principal investigator(s):
Anthony T. Yarussi, MD, Study Chair, Affiliation: Roswell Park Cancer Institute
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.
Clinical Details
Official title:
Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection
Study design: Observational, Natural History
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.
Eligibility
Gender(s): Both.
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
Locations and Contacts
Roswell Park Cancer Institute, Buffalo, New York 14263-0001, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date:
May 1992
Last updated: May 23, 2007
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