Morphine for the Treatment of Pain in Patients With Breast Cancer
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection|
|Study Start Date:||May 1992|
|Study Completion Date:||June 2001|
|Primary Completion Date:||January 2001 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003000
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|