PainNCT00003000
Morphine for the Treatment of Pain in Patients With Breast Cancer
An observational study of Pain, run by Roswell Park Cancer Institute at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages Up to 120 years
- Conditions the study is for
- Pain
- What is being tested?
- fentanyl citrate and morphine sulfate
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- May 1992to Jun 2001
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
About this study
Official title: 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.
Read the 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.
- Conditions
- Pain
- Being tested
- fentanyl citrate, morphine sulfate
- Keywords
- pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fentanyl citrateDrug
morphine sulfateDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2004 (estimated)
- Study startMay 1992
- Primary completionJan 2001
- Study completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00003000
- Sponsor's protocol ID
- CDR0000065555
- Other IDs
- RPCI-DS-92-13
- Status last verified
- Oct 2015
- First submitted
- 1 Nov 1999
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Effects of Opioid Analgesia in Patients Undergoing Axillary Node Dissection
- ClinicalTrials.gov ID
- NCT00003000
- Acronym / sponsor ID
- CDR0000065555
- Conditions
- Pain
- Keywords
- pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- May 1992
- Primary completion
- Jan 2001 (actual)
- Study completion
- Jun 2001 (actual)
- First posted
- 30 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Breast Cancer Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fentanyl citrate | Drug | – |
| morphine sulfate | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.