Back to resultsMagnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy
Primary Purpose
Cancer Breast, Chronic Pain Syndrome
Status
Recruiting
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
magnesium sulphate
bupivicaine
Sponsored by
About this trial
This is an interventional supportive care trial for Cancer Breast focused on measuring serratus anterior plane block, magnesium sulphate
Eligibility Criteria
Inclusion Criteria:
- adult female patients
- American Society Of Anesthesiologists (ASA) class I or II
- scheduled for elective unilateral modified radical mastectomy
Exclusion Criteria
- patient refusal
- bilateral breast surgery
- coagulation disorders
- body mass index> 35
- allergy to local anaesthetics or magnesium sulphate
- severe respiratory or cardiac disorders
- pre-existing neurological deficits
- liver or renal insufficiency
Sites / Locations
- Rehab Abd Elraof Abd ElazizRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group BM
Group B
Arm Description
The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.
The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml
Outcomes
Primary Outcome Measures
assessment of the pain intensity
Pain assessment by visual analogue scale
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04429893
Brief Title
Magnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy
Official Title
Effectiveness of Adding Magnesium Sulphate to Bupivicaine in Ultrasound Guided Serratus Anterior Plane Block in Patients Undergoing Modified Radical Mastectomy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
September 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Modified radical mastectomy may be associated with severe post-operative pain, leading to chronic pain syndrome which usually requires optimal perioperative pain management.
Detailed Description
Patients will be randomly into two equal groups (40 patients each) according to the adjuvant added to the local anesthetic (bupivacaine) in the serratus anterior plane block using a computer-generated random numbers concealed in sealed opaque envelopes. Group B: The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml. Group BM: The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer Breast, Chronic Pain Syndrome
Keywords
serratus anterior plane block, magnesium sulphate
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group BM
Arm Type
Experimental
Arm Description
The patients will receive 20 ml of 0.5% bupivacaine plus 150 mg magnesium sulphate in 0.9% normal saline with a total volume of 25 ml.
Arm Title
Group B
Arm Type
Active Comparator
Arm Description
The patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml
Intervention Type
Drug
Intervention Name(s)
magnesium sulphate
Intervention Description
assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy
Intervention Type
Drug
Intervention Name(s)
bupivicaine
Intervention Description
assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy
Primary Outcome Measure Information:
Title
assessment of the pain intensity
Description
Pain assessment by visual analogue scale
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult female patients
American Society Of Anesthesiologists (ASA) class I or II
scheduled for elective unilateral modified radical mastectomy
Exclusion Criteria
patient refusal
bilateral breast surgery
coagulation disorders
body mass index> 35
allergy to local anaesthetics or magnesium sulphate
severe respiratory or cardiac disorders
pre-existing neurological deficits
liver or renal insufficiency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rehab A. Abd Elaziz, Ass. Prof.
Phone
01001073703
Ext
020
Email
trcium2002@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rehab A. Abd Elaziz, Ass.Prof.
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehab Abd Elraof Abd Elaziz
City
Alexandria
State/Province
Smouha
ZIP/Postal Code
000000
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rehab A. Abd Elaziz, Ass. Prof.
Phone
01001073703
Ext
020
Email
trcium2002@yahoo.com
12. IPD Sharing Statement
Learn more about this trial
Magnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy
We'll reach out to this number within 24 hrs