- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02962024
Does Local Morphine Add to Local Anesthetics in Serratus Anterior Plane Block Has a System Analgesic Effect?
January 19, 2020 updated by: Fatma Adel El sherif,MD
Does Local Morphine Add to Local Anesthetics in Serratus Anterior Plane Block for Post Mastectomy Pain Has a System Analgesic Effect? A Clinical and Pharmacokinetics Study
the investigators aim is to investigate and explore the effect 10 mg morphine added to local anesthetics in serratus anterior plane block for post mastectomy pain management after modified radical mastectomy in patients with breast cancer with assessment of its serum level if it will be absorbed systemically or not?
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Assuit, Egypt, 171516
- South Egypt Cancer Instuite
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- (ASA) class I-II
- body weight of 50 - 90 kg
Exclusion Criteria:
- a history of bleeding diathesis,
- relevant drug allergy, opioid dependence,
- sepsis, prior surgery in the supraclavicular, infraclavicular or axillary regions, alcohol or drug abuse , patients with advanced cardiovascular disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: morphine sulphate
10mg locally morphine hydrochloride once betwwen serratus muscle and latissmus dorsi muscle
|
Other Names:
|
Placebo Comparator: bupivacaine hydrochloride
0.25%locally bupivacaine hydrochloride once
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
serum morphine level after local injection
Time Frame: 24 hours
|
concentration of serum morphine in ng/ml after local injection
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: fatma EL sherif, South Egypt Cancer Instuite, Assuit, Assuit university
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2016
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
October 1, 2018
Study Registration Dates
First Submitted
November 7, 2016
First Submitted That Met QC Criteria
November 10, 2016
First Posted (Estimate)
November 11, 2016
Study Record Updates
Last Update Posted (Actual)
January 22, 2020
Last Update Submitted That Met QC Criteria
January 19, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 348
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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