Morphine for the Treatment of Pain in Patients With Breast Cancer

Pain Clinical Trial

Official title:

Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003000
• Other study ID #: CDR0000065555
• Secondary ID: RPCI-DS-92-13
• Status: Completed
• Phase: N/A
• First received: November 1, 1999
• Last updated: October 12, 2015
• Start date: May 1992
• Est. completion date: June 2001

Study information

• Verified date: October 2015
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 2001
• Est. primary completion date: January 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 120 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• fentanyl citrate

• morphine sulfate

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States,