Morphine for the Treatment of Pain in Patients With Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00003000|
Recruitment Status : Completed
First Posted : July 30, 2004
Last Update Posted : October 14, 2015
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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.
|Condition or disease||Intervention/treatment|
|Pain||Drug: fentanyl citrate Drug: morphine sulfate|
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.
|Study Type :||Observational|
|Estimated Enrollment :||18 participants|
|Official Title:||Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection|
|Study Start Date :||May 1992|
|Actual Primary Completion Date :||January 2001|
|Actual Study Completion Date :||June 2001|
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|Ages Eligible for Study:||up to 120 Years (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003000
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Responsible Party:||Dr. Oscar Deleon, Roswell Park Cancer Institute|
|Other Study ID Numbers:||
|First Posted:||July 30, 2004 Key Record Dates|
|Last Update Posted:||October 14, 2015|
|Last Verified:||October 2015|
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents