Magnesium Sulphate to Bupivicaine in Serratus Anterior Plane Block in Modified Radical Mastectomy
Effectiveness of Adding Magnesium Sulphate to Bupivicaine in Ultrasound Guided Serratus Anterior Plane Block in Patients Undergoing Modified Radical Mastectomy
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jan 2022
Shorter than P25 for phase_2
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
First Submitted
Initial submission to the registry
June 8, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedStudy Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedAugust 2, 2022
July 1, 2022
8 months
June 8, 2020
July 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
assessment of the pain intensity
Pain assessment by visual analogue scale
24 hours
Study Arms (2)
Group BM
EXPERIMENTALThe 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.
Group B
ACTIVE COMPARATORThe patients will receive 20 ml of 0.5% bupivacaine plus 5 ml 0.9% normal saline with total volume 25 ml
Interventions
assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy
assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy
Eligibility Criteria
You may qualify if:
- adult female patients
- American Society Of Anesthesiologists (ASA) class I or II
- scheduled for elective unilateral modified radical mastectomy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rehab Abd Elraof Abd Elaziz
Alexandria, Smouha, 000000, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Rehab A. Abd Elaziz, Ass.Prof.
Alexandria University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant Professor of Anesthesia
Study Record Dates
First Submitted
June 8, 2020
First Posted
June 12, 2020
Study Start
January 1, 2022
Primary Completion
September 1, 2022
Study Completion
September 1, 2022
Last Updated
August 2, 2022
Record last verified: 2022-07