Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection
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.
Observational
Observational Model: Cohort, Time Perspective: Prospective
United States: Food and Drug Administration
CDR0000065555
NCT00003000
May 1992
June 2001
Name | Location |
---|---|
Roswell Park Cancer Institute | Buffalo, New York 14263 |