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Morphine for the Treatment of Pain in Patients With Breast Cancer

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ClinicalTrials.gov Identifier: NCT00003000
Recruitment Status : Completed
First Posted : July 30, 2004
Last Update Posted : October 14, 2015
Sponsor:
Information provided by:
Roswell Park Cancer Institute

Study Description
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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.


Condition or disease Intervention/treatment
Pain Drug: fentanyl citrate Drug: morphine sulfate

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 18 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection
Study Start Date : May 1992
Actual Primary Completion Date : January 2001
Actual Study Completion Date : June 2001

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Breast Cancer Patients
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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003000


Locations
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United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263-0001
Sponsors and Collaborators
Roswell Park Cancer Institute
More Information
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Responsible Party: Dr. Oscar Deleon, Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00003000    
Other Study ID Numbers: CDR0000065555
RPCI-DS-92-13
First Posted: July 30, 2004    Key Record Dates
Last Update Posted: October 14, 2015
Last Verified: October 2015
Keywords provided by Roswell Park Cancer Institute:
pain
Additional relevant MeSH terms:
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Fentanyl
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics