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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Regional
• Intervention / Treatment: Drug: Infusion, Lidocaine, 0.5%, 5 mL; Drug: Infusion, Lidocaine, 0.5%, 10 mL

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Capital Region Of Denmark
    • Hillerød, Capital Region Of Denmark, Denmark, 3400
      • Research Unit, Department of Anaesthesiology, Nordsjaellands Hospital Hilleroed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Right-low, left-high; 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; A catheter-based perineural infusion of 5 mL Lidocaine 0.5%; Other Names: Low dose; Drug: Infusion, Lidocaine, 0.5%, 10 mL; A catheter-based perineural infusion of 10 mL Lidocaine 0.5%; Other Names: High dose
Experimental: Right-high, left-low; 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; A catheter-based perineural infusion of 5 mL Lidocaine 0.5%; Other Names: Low dose; Drug: Infusion, Lidocaine, 0.5%, 10 mL; A catheter-based perineural infusion of 10 mL Lidocaine 0.5%; Other Names: High dose

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Nordsjaellands Hospital
• Collaborators: Innovation Fund Denmark
• Investigators: Study Director: Kai L Lange, MD, DMSci, Nordsjaellands Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2017
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: October 7, 2017
• First Submitted That Met QC Criteria: October 13, 2017
• First Posted (Actual): October 16, 2017

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 13, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: Re_Injection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No