Intra-individual Reproducibility in Nerve Block Duration

NCT03310047 | Completed Phase 1 DMC

• 1 other identifier: Re_Injection
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia, Regional

Outcome Measures

Primary Outcomes (1)

• Duration of insensitivity towards cold

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

  Up to 10 hours

Secondary Outcomes (3)

• Onset time

  Up to 30 minutes

• Degree of sensory nerve block

  Up to 10 hours

• Degree of motor nerve block

  Up to 10 hours

Study Arms (2)

Right-low, left-high

EXPERIMENTAL

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; Drug: Infusion, Lidocaine, 0.5%, 10 mL

Right-high, left-low

EXPERIMENTAL

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; Drug: Infusion, Lidocaine, 0.5%, 10 mL

Interventions

Infusion, Lidocaine, 0.5%, 5 mL DRUG

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

Also known as: Low dose

Right-high, left-low; Right-low, left-high

Infusion, Lidocaine, 0.5%, 10 mL DRUG

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

Also known as: High dose

Right-high, left-low; Right-low, left-high

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years
• ASA classification ≤ II

You may not qualify if:

• 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

Sponsors & Collaborators

• Nordsjaellands Hospital: lead
• Innovation Fund Denmark: collaborator

Study Sites (1)

Research Unit, Department of Anaesthesiology, Nordsjaellands Hospital Hilleroed

Hillerød, Capital Region of Denmark, 3400, Denmark

Location

MeSH Terms

Interventions

Lidocaine; Contraceptives, Oral

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Kai L Lange, MD, DMSci

  Nordsjaellands Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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

Study Record Dates

• First Submitted: October 7, 2017
• First Posted: October 16, 2017
• Study Start: October 30, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: May 15, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)