Morphine for the Treatment of Pain in Patients With Breast Cancer
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Purpose
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 | Intervention |
|---|---|
|
Pain |
Drug: fentanyl citrate Drug: morphine sulfate |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection |
| Estimated Enrollment: | 18 |
| Study Start Date: | May 1992 |
| Study Completion Date: | June 2001 |
| Primary Completion Date: | January 2001 (Final data collection date for primary outcome measure) |
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Breast Cancer Patients
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Dr. Oscar Deleon, Roswell Park Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00003000 History of Changes |
| Other Study ID Numbers: | CDR0000065555, RPCI-DS-92-13 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Roswell Park Cancer Institute:
|
pain |
Additional relevant MeSH terms:
|
Fentanyl Morphine Adjuvants, Anesthesia Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anesthetics, Intravenous Anesthetics, General Anesthetics Analgesics, Opioid |
ClinicalTrials.gov processed this record on May 16, 2013