Morphine for the Treatment of Pain in Patients With Breast Cancer
| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 1, 1999 |
| Last Updated Date | February 3, 2012 |
| Start Date ICMJE | May 1992 |
| Primary Completion Date | January 2001 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | Complete list of historical versions of study NCT00003000 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Morphine for the Treatment of Pain in Patients With Breast Cancer |
| Official Title ICMJE | Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection |
| 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. |
| 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 Type ICMJE | Observational |
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
| Target Follow-Up Duration | Not Provided |
| Biospecimen | Not Provided |
| Sampling Method | Probability Sample |
| Study Population | Breast Cancer Patients |
| Condition ICMJE | Pain |
| Intervention ICMJE |
|
| Study Group/Cohort (s) | Not Provided |
| Publications * | Not Provided |
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|
| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Estimated Enrollment ICMJE | 18 |
| Completion Date | June 2001 |
| Primary Completion Date | January 2001 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | 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 |
| Gender | Both |
| Ages | Not Provided |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT Number ICMJE | NCT00003000 |
| Other Study ID Numbers ICMJE | CDR0000065555, RPCI-DS-92-13 |
| Has Data Monitoring Committee | Yes |
| Responsible Party | Dr. Oscar Deleon, Roswell Park Cancer Institute |
| Study Sponsor ICMJE | Roswell Park Cancer Institute |
| Collaborators ICMJE | Not Provided |
| Investigators ICMJE | Not Provided |
| Information Provided By | Roswell Park Cancer Institute |
| Verification Date | February 2012 |
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|