ED95 of Lidocaine 1.0% for Filling the Adductor Canal | NCT02033356

NCT02033356

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2013-004462-33	EudraCT Number

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACB with 30 ml lidocaine 1%	Experimental	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.	Procedure: Adductor canal block with lidocaine 1% Drug: Lidocaine
ACB with 25 ml lidocaine 1%	Experimental	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.	Procedure: Adductor canal block with lidocaine 1% Drug: Lidocaine
ACB with 20 ml lidocaine 1%	Experimental	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.	Procedure: Adductor canal block with lidocaine 1% Drug: Lidocaine
ACB with 15 ml lidocaine 1%	Experimental	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adductor canal block with lidocaine 1%	Procedure	US-guided adductor canal block	ACB with 10 ml lidocaine 1% ACB with 15 ml lidocaine 1% ACB with 20 ml lidocaine 1%

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To estimate the ED 95 for the volume needed to fill the adductor canal distally.	This will be evaluated as a binary outcome using MRI; where the adductor canal is considered to be filled if the lidocaine injectate can be identified inside the canal in the first slice distally to the insertion of the adductor longus muscle on femur.	MRI performed 15 minutes post block

Secondary Outcomes

Measure	Description	Time Frame
To investigate the effect of volume on proximal spread to the femoral triangle	Evaluated as a binary outcome using MRI	MRI performed 15 minutes post block
Quadriceps muscle strength	To investigate the effect of volume on quadriceps muscle strength, assessed as maximum voluntary isometric contraction (MVIC) and evaluated as a binary outcome (reduction by more or less than 25%).

Eligibility Module

Name	Affiliation	Role
Pia Jaeger, MD	Department of Anaesthesia, HOC, Rigshospitalet, Denmark	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Aleris-Hamlet Hospitals Copenhagen		Søborg		2860	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26582853	Derived	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.