Intra-individual Reproducibility in Nerve Block Duration

Nordsjaellands Hospital20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Anesthesia, Regional

Interventions

Infusion, Lidocaine, 0.5%, 5 mLDRUG

A catheter-based perineural infusion of 5 mL Lidocaine 0.5%

Infusion, Lidocaine, 0.5%, 10 mLDRUG

A catheter-based perineural infusion of 10 mL Lidocaine 0.5%

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Research Unit, Department of Anaesthesiology, Nordsjaellands Hospital Hilleroed

Hillerød, Capital Region of Denmark, Denmark

Outcomes

Primary Outcomes

Duration of insensitivity towards cold

Time from nerve block onset time (T1) to nerve block remission (T2)

Time frame: Up to 10 hours

Secondary Outcomes

Onset time

Time from infusion (T0) to onset (T1) of the nerve blocking effect

Time frame: 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.

Time frame: 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.

Time frame: Up to 10 hours

Data from ClinicalTrials.gov

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