Back to resultsDoes Local Morphine Add to Local Anesthetics in Serratus Anterior Plane Block Has a System Analgesic Effect?
Primary Purpose
Postoperative Complications
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Morphine Sulfate
Bupivacaine Hydrochloride
Sponsored by
About this trial
This is an interventional health services research trial for Postoperative Complications
Eligibility Criteria
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
Sites / Locations
- South Egypt Cancer Instuite
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
morphine sulphate
bupivacaine hydrochloride
Arm Description
10mg locally morphine hydrochloride once betwwen serratus muscle and latissmus dorsi muscle
0.25%locally bupivacaine hydrochloride once
Outcomes
Primary Outcome Measures
serum morphine level after local injection
concentration of serum morphine in ng/ml after local injection
Secondary Outcome Measures
Full Information
NCT ID
NCT02962024
First Posted
November 7, 2016
Last Updated
January 19, 2020
Sponsor
Fatma Adel El sherif,MD
1. Study Identification
Unique Protocol Identification Number
NCT02962024
Brief Title
Does Local Morphine Add to Local Anesthetics in Serratus Anterior Plane Block Has a System Analgesic Effect?
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Fatma Adel El sherif,MD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
morphine sulphate
Arm Type
Active Comparator
Arm Description
10mg locally morphine hydrochloride once betwwen serratus muscle and latissmus dorsi muscle
Arm Title
bupivacaine hydrochloride
Arm Type
Placebo Comparator
Arm Description
0.25%locally bupivacaine hydrochloride once
Intervention Type
Drug
Intervention Name(s)
Morphine Sulfate
Other Intervention Name(s)
morphine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride
Other Intervention Name(s)
marcaine
Primary Outcome Measure Information:
Title
serum morphine level after local injection
Description
concentration of serum morphine in ng/ml after local injection
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fatma EL sherif
Organizational Affiliation
South Egypt Cancer Instuite, Assuit, Assuit university
Official's Role
Study Director
Facility Information:
Facility Name
South Egypt Cancer Instuite
City
Assuit
ZIP/Postal Code
171516
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32280268
Citation
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.
Results Reference
derived
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Does Local Morphine Add to Local Anesthetics in Serratus Anterior Plane Block Has a System Analgesic Effect?
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