Analgesic Efficacy of Magnesium Sulphate as an Adjuvant to Levobupivacaine in Erector Spinae Block for Acute Pain Management in Modified Radical Mastectomy
1 other identifier
interventional
40
1 country
1
Brief Summary
To evaluate the analgesic efficacy of magnesium sulphate as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery for acute pain management
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Dec 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2019
CompletedFirst Submitted
Initial submission to the registry
January 9, 2021
CompletedFirst Posted
Study publicly available on registry
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2021
CompletedFebruary 1, 2021
January 1, 2021
1.2 years
January 9, 2021
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
analgesia request
first request for analgesia .
24 hours
Study Arms (2)
GROUP(A) (CONTROL GROUP)
PLACEBO COMPARATORPatient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5.
Group (M)
ACTIVE COMPARATORPatient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5. .
Interventions
Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5
Patient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5.
Eligibility Criteria
You may qualify if:
- female patient
- American society of anesthesiologists (ASA) I and II physical status
- age from 25 to 70 years old
- scheduled for either left or right modified radical mastectomy (MRM)
You may not qualify if:
- infection of the skin at or near site of needle puncture
- coagulopathy,
- drug hypersensitivity or allergy to the studied drugs,
- central or peripheral neuropathy,
- significant organ dysfunction cardiac dysrrhythmias,
- obesity (BMI\>35kg/m2)
- recently use analgesic drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Egypt Cancer Institute
Asyut, 171516, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
peter R Edward, MSc
specialist
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
January 9, 2021
First Posted
February 1, 2021
Study Start
December 1, 2019
Primary Completion
February 1, 2021
Study Completion
July 1, 2021
Last Updated
February 1, 2021
Record last verified: 2021-01