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Completed

NCT Number: NCT03310047

Intra-individual Reproducibility in Nerve Block Duration

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

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Key information

Conditions

Anesthesia, Regional

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Unit, Department of Anaesthesiology, Nordsjaellands Hospital Hilleroed

Hillerød, Capital Region of Denmark, 3400, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infusion, Lidocaine, 0.5%, 5 mL

Drug

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

Other names: Low dose

Infusion, Lidocaine, 0.5%, 10 mL

Drug

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

Other names: High dose

Primary outcomes

  1. Duration of insensitivity towards cold

    Time frame: Up to 10 hours

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

Secondary outcomes

  1. Onset time

    Time frame: Up to 30 minutes

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

  2. Degree of sensory nerve block

    Time frame: Up to 10 hours

    A four step grading-scale of sensory nerve block intensity. 1 = normal, 2 = different, 3 = warm, 4 = no feeling.

  3. Degree of motor nerve block

    Time frame: Up to 10 hours

    A three step grading-scale of motor nerve block intensity. 1 = normal, 2 = decreased strength, 3 = no strength.

Sponsors and collaborators

Lead sponsor

Nordsjaellands Hospital

Other

Collaborators

  • Innovation Fund Denmark

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2017
Registry last updated
May 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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