Intra-individual Reproducibility in Nerve Block Duration
NCT ID: NCT03310047
Last Updated: 2018-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
20 participants
INTERVENTIONAL
2017-10-30
2018-03-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effects of Local Anaesthetic Infusion Rates on Nerve Block Duration
NCT02801799
The Effect of Local Anaesthetic Volume on Nerve Block Duration and Nerve Block Duration Variability
NCT02829697
Does Perineural Clonidine Prolong Duration of a Nerve Block?
NCT02444559
Effect of the Transmuscular Quadratus Lumborum Block on Duration of Stay in Recovery
NCT04951752
Determination of the Duration of Action of a Lidocaine and a Bupivacaine Digital Nerve Block in Human Volunteers
NCT01508832
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
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
BASIC_SCIENCE
TRIPLE
Investigators will not be in the room during the intervention. Outcome assessors will not be in the room during the intervention.
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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%
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.
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%
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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%
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. ASA classification ≤ II
Exclusion Criteria
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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Innovation Fund Denmark
INDIV
Nordsjaellands Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mikkel Herold Madsen
Principal investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kai L Lange, MD, DMSci
Role: STUDY_DIRECTOR
Nordsjaellands Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Research Unit, Department of Anaesthesiology, Nordsjaellands Hospital Hilleroed
Hillerød, Capital Region of Denmark, Denmark
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Re_Injection
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.