Does Local Morphine Add to Local Anesthetics in Serratus Anterior Plane Block Has a System Analgesic Effect?
1 other identifier
interventional
40
1 country
1
Brief Summary
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?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedFirst Submitted
Initial submission to the registry
November 7, 2016
CompletedFirst Posted
Study publicly available on registry
November 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedJanuary 22, 2020
January 1, 2020
1.5 years
November 7, 2016
January 19, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
serum morphine level after local injection
concentration of serum morphine in ng/ml after local injection
24 hours
Study Arms (2)
morphine sulphate
ACTIVE COMPARATOR10mg locally morphine hydrochloride once betwwen serratus muscle and latissmus dorsi muscle
bupivacaine hydrochloride
PLACEBO COMPARATOR0.25%locally bupivacaine hydrochloride once
Interventions
Eligibility Criteria
You may qualify if:
- (ASA) class I-II
- body weight of 50 - 90 kg
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Egypt Cancer Instuite
Asyut, 171516, Egypt
Related Publications (1)
El Sherif FA, Abd El-Rahman AM, Othman AH, Shouman SA, Omran MM, Hassan NA, Hassan SB, Aboeleuon E. Analgesic Effect of Morphine Added to Bupivacaine in Serratus Anterior Plane Block Following Modified Radical Mastectomy. Only a Local Effect? Randomized Clinical Trial. J Pain Res. 2020 Mar 31;13:661-668. doi: 10.2147/JPR.S236336. eCollection 2020.
PMID: 32280268DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
fatma EL sherif
South Egypt Cancer Instuite, Assuit, Assuit university
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- lecturer of anesthesia, ICU and pain management
Study Record Dates
First Submitted
November 7, 2016
First Posted
November 11, 2016
Study Start
November 1, 2016
Primary Completion
May 1, 2018
Study Completion
October 1, 2018
Last Updated
January 22, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share