Analgesic Efficacy of Dexmedetomidine as Adjuvant to Levobupivacaine in Ultrasound-guided Erector Spinae Plan Block for Modified Radical Mastectomy
1 other identifier
interventional
40
1 country
1
Brief Summary
To evaluate the analgesic efficacy of dexmedetomidine as adjuvants to levobupivacaine in erector spinae plane block in modified radical mastectomy surgery.
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 Nov 2020
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
Study Start
First participant enrolled
November 1, 2020
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
November 28, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2021
CompletedFebruary 1, 2021
January 1, 2021
1.1 years
January 9, 2021
January 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Analgesia required
time of 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 (D)
ACTIVE COMPARATORPatient will receive 20ml 0.25% levobupivacaine above + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5.
Interventions
Group (A) (control group): 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 above + 1μ/kg dexmedetomidine 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
- specialist
Study Record Dates
First Submitted
January 9, 2021
First Posted
February 1, 2021
Study Start
November 1, 2020
Primary Completion
November 28, 2021
Study Completion
December 28, 2021
Last Updated
February 1, 2021
Record last verified: 2021-01