Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2014-01-31
2014-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ACB with 30 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
Adductor canal block with lidocaine 1%
US-guided adductor canal block
Lidocaine
ACB with 25 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
Adductor canal block with lidocaine 1%
US-guided adductor canal block
Lidocaine
ACB with 20 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
Adductor canal block with lidocaine 1%
US-guided adductor canal block
Lidocaine
ACB with 15 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
Adductor canal block with lidocaine 1%
US-guided adductor canal block
Lidocaine
ACB with 10 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
Adductor canal block with lidocaine 1%
US-guided adductor canal block
Lidocaine
ACB with 5 ml lidocaine 1%
Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml.
Adductor canal block with lidocaine 1%
US-guided adductor canal block
Lidocaine
Interventions
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Adductor canal block with lidocaine 1%
US-guided adductor canal block
Lidocaine
Eligibility Criteria
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Inclusion Criteria
* Men
* American Society of Anesthesiologists' class 1
* Body Mass Index 18-25
Exclusion Criteria
* Earlier trauma or surgery to the lower limb
* Diabetes Mellitus - Contraindications to MRI
18 Years
30 Years
FEMALE
Yes
Sponsors
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Rigshospitalet, Denmark
OTHER
Responsible Party
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Pia Jaeger
MD
Principal Investigators
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Pia Jaeger, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Anaesthesia, HOC, Rigshospitalet, Denmark
Locations
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Aleris-Hamlet Hospitals Copenhagen
Søborg, , Denmark
Countries
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References
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Jaeger P, Jenstrup MT, Lund J, Siersma V, Brondum V, Hilsted KL, Dahl JB. Optimal volume of local anaesthetic for adductor canal block: using the continual reassessment method to estimate ED95. Br J Anaesth. 2015 Dec;115(6):920-6. doi: 10.1093/bja/aev362.
Other Identifiers
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2013-004462-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SM3-PJ-13
Identifier Type: -
Identifier Source: org_study_id
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