Intra-individual Reproducibility in Nerve Block Duration

Study Overview
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Brief Summary
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An interventional randomized controlled crossover trial, to illuminate if durations in nerve block durations are predictable within the same subject.

Detailed Description
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An interventional randomized controlled crossover trial, with the purpose to elucidate the reproducibility in nerve block duration on 20 healthy volunteers in Denmark. There will be two trial arms: 1: Day one; Right side low dose nerve block and left side high dose nerve block. Repeated after 24 hours. Day three; Left side low dose nerve block and right side high dose nerve block. Repeated after 24 hours 2: Day one; Left side low dose nerve block and right side high dose nerve block Repeated after 24 hours Day three; Right side low dose nerve block and left side high dose nerve block Repeated after 24 hours All volunteers will receive two peripheral nerve blocking catheters adjacent to the common peroneal nerve and will be treated two times on each side with Lidocaine 0.5% 5 mL and 10 mL.

Official Title
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Intra-individual Reproducibility in Nerve Block Duration

Conditions
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Anesthesia, Regional

Intervention / Treatment
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* Drug: Infusion, Lidocaine, 0.5%, 5 mL
* Drug: Infusion, Lidocaine, 0.5%, 10 mL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 years ASA classification ≤ II Exclusion Criteria: Allergy to local anaesthetics Body weight 40 kg Possible peripheral nerve injury or disease, including polyneuropathy and diabetes Enrolment or recent participation in studies that may interfere with this study Habitual use of any kind of analgesic medications Anatomic abnormalities preventing successful US-guided Certa Catheter™ insertion. Pregnancy or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: We will use a two-armed crossover design. Day one; Right side low dose nerve block and left side high dose nerve block Repeated after 24 hours Day three; Left side low dose nerve block and right side high dose nerve block Repeated after 24 hours Day one; Left side low dose nerve block and right side high dose nerve block Repeated after 24 hours Day three; Right side low dose nerve block and left side high dose nerve block Repeated after 24 hours
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Right-low, left-high<br>The right-side perineural catheter will be subject to intervention drug Infusion, Lidocaine, 0.5%, 5 mL Lidocaine and the left side perineural catheter will be subject to intervention Infusion, Lidocaine, 0.5%, 10 mL. This will be repeated after 24 hours. | Drug: Infusion, Lidocaine, 0.5%, 5 mL<br>* A catheter-based perineural infusion of 5 mL Lidocaine 0.5%<br>* Other names: Low dose;Drug: Infusion, Lidocaine, 0.5%, 10 mL<br>* A catheter-based perineural infusion of 10 mL Lidocaine 0.5%<br>* Other names: High dose;|
| Experimental: Right-high, left-low<br>The right-side perineural catheter will be subject to intervention drug Infusion, Lidocaine, 0.5%, 10 mL Lidocaine and the left side perineural catheter will be subject to intervention Infusion, Lidocaine, 0.5%, 5 mL. This will be repeated after 24 hours. | Drug: Infusion, Lidocaine, 0.5%, 5 mL<br>* A catheter-based perineural infusion of 5 mL Lidocaine 0.5%<br>* Other names: Low dose;Drug: Infusion, Lidocaine, 0.5%, 10 mL<br>* A catheter-based perineural infusion of 10 mL Lidocaine 0.5%<br>* Other names: High dose;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of insensitivity towards cold | Time from nerve block onset time (T1) to nerve block remission (T2) | Up to 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset time | Time from infusion (T0) to onset (T1) of the nerve blocking effect | Up to 30 minutes | 
| Degree of sensory nerve block | A four step grading-scale of sensory nerve block intensity. 1 = normal, 2 = different, 3 = warm, 4 = no feeling. | Up to 10 hours | 
| Degree of motor nerve block | A three step grading-scale of motor nerve block intensity. 1 = normal, 2 = decreased strength, 3 = no strength. | Up to 10 hours |