ED95 of Lidocaine 1.0% for Filling the Adductor Canal

Rigshospitalet

Status and phase: Completed; Phase 2

Conditions: Healthy

Treatments: Procedure: Adductor canal block with lidocaine 1%; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02033356

2013-004462-33 (EudraCT Number)

SM3-PJ-13

Details and patient eligibility

About

The aim of this prospective dose finding study is to estimate the minimal effective volume (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal block. We will apply the Continual Reassessment Method (CRM) for estimating the ED95 and use an MRI scan to evaluate the main objective and ensure spread to the distal part of the adductor canal.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-30 years
• Men
• American Society of Anesthesiologists' class 1
• Body Mass Index 18-25

Exclusion criteria

• Allergy to study medication
• Earlier trauma or surgery to the lower limb
• Diabetes Mellitus - Contraindications to MRI

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 6 patient groups

ACB with 30 ml lidocaine 1%

Experimental group

Description:

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.

Treatment:

Procedure: Adductor canal block with lidocaine 1%

Drug: Lidocaine

ACB with 25 ml lidocaine 1%

Experimental group

Description:

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.

Treatment:

Procedure: Adductor canal block with lidocaine 1%

Drug: Lidocaine

ACB with 20 ml lidocaine 1%

Experimental group

Description:

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.

Treatment:

Procedure: Adductor canal block with lidocaine 1%

Drug: Lidocaine

ACB with 15 ml lidocaine 1%

Experimental group

Description:

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.

Treatment:

Procedure: Adductor canal block with lidocaine 1%

Drug: Lidocaine

ACB with 10 ml lidocaine 1%

Experimental group

Description:

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.

Treatment:

Procedure: Adductor canal block with lidocaine 1%

Drug: Lidocaine

ACB with 5 ml lidocaine 1%

Experimental group

Description:

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.

Treatment:

Procedure: Adductor canal block with lidocaine 1%

Drug: Lidocaine