Clinical Trial: Morphine for the Treatment of Pain in Patients With Breast Cancer

This study is no longer recruiting patients.

Sponsored by: Roswell Park Cancer Institute
Information provided by: National Cancer Institute (NCI)

Purpose

RATIONALE: Morphine helps to relieve the pain associated with cancer surgery. Giving morphine in different ways may offer more pain relief.

PURPOSE: Randomized clinical trial to compare the effectiveness of morphine injected directly into the underarm area 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 Treatment or Intervention
Pain
 Drug: fentanyl
 Drug: morphine

MedlinePlus related topics:  Pain

Study Type: Interventional
Study Design: Educational/Counseling/Training

Official Title: Randomized Study of the Peripheral Effects of Opioid Analgesia in Patients with Breast Cancer Undergoing Axillary Node Dissection

Further Study Details: 

Study start: May 1992

OBJECTIVES:

I. Determine whether morphine injected at the site of surgery can control pain from surgery.

PROTOCOL 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.

Eligibility

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--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

Location Information


New York
      Roswell Park Cancer Institute, Buffalo,  New York,  14263-0001,  United States

Study chairs or principal investigators

Anthony T. Yarussi,  Study Chair,  Roswell Park Cancer Institute   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000065555; RPCI-DS-92-13; NCI-V97-1251
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003000
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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