Anesthesia, Regional
Conditions
Brief summary
An interventional randomized controlled crossover trial, to illuminate if durations in nerve block durations are predictable within the same subject.
Detailed description
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.
Interventions
DRUGInfusion, Lidocaine, 0.5%, 5 mL
A catheter-based perineural infusion of 5 mL Lidocaine 0.5%
DRUGInfusion, Lidocaine, 0.5%, 10 mL
A catheter-based perineural infusion of 10 mL Lidocaine 0.5%
Sponsors
Innovation Fund Denmark
Nordsjaellands Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
The process of intervention-implementation and intervention will not be in the participant's line of sight. Investigators will not be in the room during the intervention. Outcome assessors will not be in the room during the intervention.
Intervention model description
We will use a two-armed crossover design. 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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Age 18 years 2. ASA classification ≤ II
Exclusion criteria
1. Allergy to local anaesthetics 2. Body weight 40 kg 3. Possible peripheral nerve injury or disease, including polyneuropathy and diabetes 4. Enrolment or recent participation in studies that may interfere with this study 5. Habitual use of any kind of analgesic medications 6. Anatomic abnormalities preventing successful US-guided Certa Catheter™ insertion. 7. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of insensitivity towards cold | Up to 10 hours | Time from nerve block onset time (T1) to nerve block remission (T2) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Onset time | Up to 30 minutes | Time from infusion (T0) to onset (T1) of the nerve blocking effect |
| Degree of sensory nerve block | Up to 10 hours | A four step grading-scale of sensory nerve block intensity. 1 = normal, 2 = different, 3 = warm, 4 = no feeling. |
| Degree of motor nerve block | Up to 10 hours | A three step grading-scale of motor nerve block intensity. 1 = normal, 2 = decreased strength, 3 = no strength. |
Countries
Denmark
Outcome results
None listed