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Morphine for the Treatment of Pain in Patients With Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT00003000
First received: November 1, 1999
Last updated: February 3, 2012
Last verified: February 2012

November 1, 1999
February 3, 2012
May 1992
January 2001   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003000 on ClinicalTrials.gov Archive Site
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Morphine for the Treatment of Pain in Patients With Breast Cancer
Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

Breast Cancer Patients

Pain
  • Drug: fentanyl citrate
  • Drug: morphine sulfate
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
June 2001
January 2001   (final data collection date for primary outcome measure)

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

Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003000
CDR0000065555, RPCI-DS-92-13
Yes
Dr. Oscar Deleon, Roswell Park Cancer Institute
Roswell Park Cancer Institute
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Roswell Park Cancer Institute
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP