Effect of Dexmedetomidine on the Duration of Pain Control in ESP Block for Breast Surgery
Addition of Dexmedetomidine to Ropivacaine for Ultrasound Guided Erector Spinae Block: Evaluation of Effect on Postoperative Pain After Breast Surgery: A Double-Blinded, Prospective, Randomized Clinical Trial
1 other identifier
interventional
44
1 country
1
Brief Summary
Patients undergoing Partial or total mastectomy with axillary LN dissection will receive prior to induction of general anaesthesia ESP block at T4 level at the same side of the surgery. one group will receive ropivacaine 0.375% and the other will get ropivacaine 0.375% with dexmedetomidine 0.5mcg/kg as an adjuvant. time to first narcotic requirement will be documented and therefore an assessment of the duration of action of the block will be made
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 breast-cancer
Started Jul 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
First Submitted
Initial submission to the registry
July 17, 2019
CompletedStudy Start
First participant enrolled
July 17, 2019
CompletedFirst Posted
Study publicly available on registry
July 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2022
CompletedFebruary 23, 2021
February 1, 2021
2 years
July 17, 2019
February 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain assessment in the first 24 hours post operatively: VAS score
Pain will be assessed using the VAS score ranging from 0, indicating no pain at all, to 10, indicating the worst pain the patient has ever felt
24 hours
Study Arms (2)
Precedex
ACTIVE COMPARATORparticipants will receive an ESP block with 20 ml Ropivacaine 0.375% in the induction room 20 minutes before their operation
Dexmedetomidine
EXPERIMENTALparticipants will receive an ESP block with 20 ml Ropivacaine 0.375% + 0.5mcg/kg dexmedetomidine in the induction room 20 minutes before their operation
Interventions
addition of dexmedetomidine to ropivacaine as an adjuvant in ESP block to assess wether or not it prolongs its duration of action
Eligibility Criteria
You may qualify if:
- ASA class I, II and III patients
- Age range: 18-80 years old
- Elective partial or unilateral radical mastectomy with sentinel lymph node dissection
You may not qualify if:
- Pregnant woman
- Bilateral mastectomy.
- Skin infection at the site of needle puncture
- Coagulopathy problems
- Allergy or contraindication to any of the study drugs
- Recent use of opioid drugs
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Lebanese American University Medical Center-Rizk Hospital
Beirut, Lebanon
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Instructor, Director Anaesthesiology Residency Program
Study Record Dates
First Submitted
July 17, 2019
First Posted
July 23, 2019
Study Start
July 17, 2019
Primary Completion
July 17, 2021
Study Completion
January 17, 2022
Last Updated
February 23, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share