Intra-individual Reproducibility in Nerve Block Duration

Anesthesia, Regional Clinical Trial

Official title:

Intra-individual Reproducibility in Nerve Block Duration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03310047
• Other study ID #: Re_Injection
• Status: Completed
• Phase: Phase 1
• Start date: October 30, 2017
• Est. completion date: March 1, 2018

Study information

• Verified date: May 2018
• Source: Nordsjaellands Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, Regional

Intervention

Drug:
• Infusion, Lidocaine, 0.5%, 5 mL
A catheter-based perineural infusion of 5 mL Lidocaine 0.5%
• Infusion, Lidocaine, 0.5%, 10 mL
A catheter-based perineural infusion of 10 mL Lidocaine 0.5%

Locations

Country	Name	City	State
Denmark	Research Unit, Department of Anaesthesiology, Nordsjaellands Hospital Hilleroed	Hillerød	Capital Region Of Denmark

Sponsors (2)

Lead Sponsor	Collaborator
Nordsjaellands Hospital	Innovation Fund Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of insensitivity towards cold	Time from nerve block onset time (T1) to nerve block remission (T2)	Up to 10 hours
Secondary	Onset time	Time from infusion (T0) to onset (T1) of the nerve blocking effect	Up to 30 minutes
Secondary	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
Secondary	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