The Effect of Different Doses (Mass) of Local Anesthetic on Duration of Adductor Canal Block in Healthy Volunteers - Part 2

Rigshospitalet

Status and phase: Completed; Phase 4

Conditions: Healthy

Treatments: Drug: Adductor canal block with 20 ml lidocaine, single bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT02172729

SM1-PJ-14

2014-001752-31 (EudraCT Number)

Details and patient eligibility

About

To investigate whether increased dose of local anesthetic (lidocaine) increases duration of peripheral nerve block (adductor canal block) and to develop a model for assessing duration of peripheral nerve blockades. The investigators hypothesize that increasing the dose of lidocaine (by increased concentration) will increase the duration of an adductor canal block.

The study is a follow up on an identical study (SM1-PJ-13, EudraCT number: 2013-001822-24 ) made earlier with different concentrations of lidocaine and a placebo group. For further information see trial registration at European Union Drug Regulatory Authorities Clinical Trial System.

Enrollment: 14 patients

Sex: Male

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• ASA 1
• Body mass index 18-25

Exclusion criteria

• Allergy to study medication
• Earlier trauma or surgery to lower limb
• Diabetes Mellitus

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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14 participants in 2 patient groups

ACB with lidocaine 5 mg/ml

Experimental group

Description:

Adductor canal block (ACB) with 20 ml lidocaine 5 mg/ml, single bolus

Treatment:

Drug: Adductor canal block with 20 ml lidocaine, single bolus

ACB with lidocaine 15 mg/ml

Experimental group

Description:

Adductor canal block with 20 ml lidocaine 15 mg/ml, single bolus

Treatment:

Drug: Adductor canal block with 20 ml lidocaine, single bolus