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Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection


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Not Enrolling
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Pain

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Trial Information

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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000065555

NCT ID:

NCT00003000

Start Date:

May 1992

Completion Date:

June 2001

Related Keywords:

  • Pain
  • pain

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263