Ropivacaine Pharmacokinetics After Erector Spinae Block
PK
1 other identifier
interventional
46
0 countries
N/A
Brief Summary
The primary aim is to evaluate the analgesic efficacy of either technique by measuring cumulative morphine consumption in the first 24 hours after an erector spinae plane block with 2 ml/kg of ropivacaine 0.1% (2 ml/kg) or 1 ml/kg of ropivacaine 0.2%. The secondary aim of this study is to describe the pharmacokinetics of ropivacaine 0.1% and ropivacaine 0.2% after erector spinae block in children undergoing posterior spinal fusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 pain
Started Jun 2023
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
February 10, 2023
CompletedFirst Posted
Study publicly available on registry
March 6, 2023
CompletedStudy Start
First participant enrolled
June 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedApril 14, 2023
April 1, 2023
9 months
February 10, 2023
April 13, 2023
Conditions
Outcome Measures
Primary Outcomes (4)
Opioid Consumption
Total opioid consumption after surgery
24 hours after surgery
Pain after surgery
Severity of pain after surgery measured by heart rate variability
24 hours after the surgery
Pain during surgery
Severity of pain during surgery during measured by heart rate variability
During the the surgery
Post-operative Complications
The number of anesthesia and surgical related complications
24 hours after the surgery
Secondary Outcomes (1)
Secondary outcome
During the and 24 hours after the surgery
Study Arms (2)
Ropivacaine 0.1%
ACTIVE COMPARATORErector spinae plane block with 2 ml/kg of ropivacaine 0.1%.
Ropivacaine 0.2%
EXPERIMENTALErector spinae plane block with 1 ml/kg of ropivacaine 0.2%.
Interventions
Eligibility Criteria
You may qualify if:
- Patients ≥ 8 year older and \> 25 kg undergoing posterior spinal fusion surgery
- Parents or legal guardians that are fluent in French of English
You may not qualify if:
- Patients with any contraindication to locoregional anesthesia
- Patients that are expected to be intubation for a prolonged period of time after surgery
- Patients with anemia (hematocrit \< 30%) before surgery or at time of the first study blood draw
- Patients that do not receive an erector spinae plane block
- Parents or legal Patient/legal guardian that to not consent to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas Engelhardt, MD, PhD
McGill University Health Centre/Research Institute of the McGill University Health Centre
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Inverstigator
Study Record Dates
First Submitted
February 10, 2023
First Posted
March 6, 2023
Study Start
June 1, 2023
Primary Completion
March 1, 2024
Study Completion
November 1, 2024
Last Updated
April 14, 2023
Record last verified: 2023-04