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Clinical Trials/NCT00003000
NCT00003000
Completed
Not Applicable

Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection

Roswell Park Cancer Institute1 site in 1 country18 target enrollmentMay 1992
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Roswell Park Cancer Institute
Enrollment
18
Locations
1
Status
Completed
Last Updated
10 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
May 1992
End Date
June 2001
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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