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

Study Overview
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Brief Summary
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Adductor canal block with 20 ml lidocaine, single bolus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ASA 1 Body mass index 18-25 Exclusion Criteria: Allergy to study medication Earlier trauma or surgery to lower limb Diabetes Mellitus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ACB with lidocaine 5 mg/ml<br>Adductor canal block (ACB) with 20 ml lidocaine 5 mg/ml, single bolus | Drug: Adductor canal block with 20 ml lidocaine, single bolus<br>* Duration of an adductor canal block with 20 ml lidocaine, single bolus, administered as 5 or 15 mg/ml<br>|
| Experimental: ACB with lidocaine 15 mg/ml<br>Adductor canal block with 20 ml lidocaine 15 mg/ml, single bolus | Drug: Adductor canal block with 20 ml lidocaine, single bolus<br>* Duration of an adductor canal block with 20 ml lidocaine, single bolus, administered as 5 or 15 mg/ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of sensory block assessed with pinprick. | Duration is defined as the time from block performance until recovery of sensation to pin-prick stimulus, assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of sensory block assessed by heat pain detection threshold | Duration is defined as time from block performance until recovery of normal sensation (+/- 2 degrees Celsius from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-10 hours | 
| Duration of sensory block assessed by warmth detection threshold | Duration is defined as time from block performance until recovery of normal sensation (return to baseline value + 2 degrees Celsius or less from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-10 hours | 
| Duration of sensory block assessed by pain during 1 minute of warmth stimulation | Duration is defined as time from block performance until recovery of normal sensation (return to baseline VAS pain scores +/-10 mm from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-10 hours | 
| Duration of sensory block assessed by tolerance to transcutaneal electrical stimulation | Duration is defined as time from block performance until recovery of normal sensation (return to baseline preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-10 hours | 
| Duration of sensory block assessed by cold sensation with an alcohol swab | Duration is defined as time from block performance until recovery of normal sensation assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-10 hours | 
| Duration of motor block assessed as maximum voluntary isometric contraction. | Duration is defined as time from block performance until recovery of normal muscle strength, assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-10 hours | 
| Time to onset of sensory block assessed by pinprick. | Onset is defined as the time from block performance until loss of sensation to pin-prick stimulus assessed at 30 and 60 minutes post block, and thereafter every hour. | 0-2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthetics, Local, Sensation, adductor canal block, healthy volunteers, US-guided peripheral nerve block, lower limb, duration, Muscle Strength