Minimum Effective Volume of Lidocaine Costoclavicular Brachial Plexus Block
1 other identifier
interventional
60
1 country
1
Brief Summary
The aim of this study is to determine the minimum effective volume of lidocaine in 90% of patients (ED90) required for single-injection US-guided costoclavicular infraclavicular.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2016
Shorter than P25 for not_applicable
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
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 12, 2016
CompletedFirst Posted
Study publicly available on registry
October 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2017
CompletedMarch 22, 2017
March 1, 2017
3 months
October 12, 2016
March 21, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
success rate
minimal composite score of 14 out of 16
0-30 min
Study Arms (2)
costoclavicular inflaclavicular block
ACTIVE COMPARATORcostoclavicular block with similar volume
costoclavicular block
EXPERIMENTALcostoclavicular block with decreasing volume
Interventions
ultrasound-guided costoclavicular nerve block
Eligibility Criteria
You may qualify if:
- age between 18 and 70 years
- American Society of Anesthesiologists classification 1-3
- body mass index between 20 and 30
You may not qualify if:
- adults who are unable to give their own consent
- pre-existing neuropathy (assessed by history and physical examination)
- coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets≤ 100, International Normalized Ratio≥ 1.4 or partial prothrombin time ≥ 50)
- renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine≥ 100)
- hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases≥ 100)
- allergy to local anesthetics
- pregnancy
- prior surgery in the infraclavicular region
- chronic pain syndromes requiring opioid intake at home
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montreal General Hospital
Montreal, Quebec, H3G-1A4, Canada
Related Publications (1)
Sotthisopha T, Elgueta MF, Samerchua A, Leurcharusmee P, Tiyaprasertkul W, Gordon A, Finlayson RJ, Tran DQ. Minimum Effective Volume of Lidocaine for Ultrasound-Guided Costoclavicular Block. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):571-574. doi: 10.1097/AAP.0000000000000629.
PMID: 28723837DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
De QH Tran, MD
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 12, 2016
First Posted
October 13, 2016
Study Start
October 1, 2016
Primary Completion
January 1, 2017
Study Completion
February 1, 2017
Last Updated
March 22, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will not share