Completed

Morphine's Local and Systemic Effects on Postoperative Pain Control in Axillary Node Dissection Patients

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What is being collected

Drug Data

+ drug Data

Collected from today forward - Prospective
Drug
Who is being recruted

Neurologic Manifestations+1

+ Signs and Symptoms

+ Pathological Conditions, Signs and Symptoms

Until 120 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: May 1992
See protocol details

Summary

Principal SponsorRoswell Park Cancer Institute
Last updated: October 14, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 1992

Actual date on which the first participant was enrolled.

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.

NCT00003000
Principal SponsorRoswell Park Cancer Institute
Last updated: October 14, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

18 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Until 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPain

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Roswell Park Cancer Institute

Buffalo, United StatesOpen Roswell Park Cancer Institute in Google Maps
CompletedOne Study Center