Anesthesia, RegionalPhase 1NCT03310047
Intra-individual Reproducibility in Nerve Block Duration
A Phase 1 study testing Infusion, Lidocaine, 0.5%, 5 mL and Infusion, Lidocaine, 0.5%, 10 mL in people with Anesthesia, Regional, run by Nordsjaellands Hospital at 1 site in Denmark.
Trial summary
An interventional randomized controlled crossover trial, to illuminate if durations in nerve block durations are predictable within the same subject. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anesthesia, Regional
- What is being tested?
- Infusion, Lidocaine, 0.5%, 5 mL and Infusion, Lidocaine, 0.5%, 10 mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 30 Oct 2017to 1 Mar 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years
- ASA classification ≤ II
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Research Unit, Department of Anaesthesiology, Nordsjaellands Hospital Hilleroed
Hillerød, Capital Region of Denmark, 3400
About this study
An interventional randomized controlled crossover trial, to illuminate if durations in nerve block durations are predictable within the same subject.
Read the 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.
- Conditions
- Anesthesia, Regional
- Being tested
- Infusion, Lidocaine, 0.5%, 5 mL, Infusion, Lidocaine, 0.5%, 10 mL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion, Lidocaine, 0.5%, 5 mLDrug
Also called Low dose
A catheter-based perineural infusion of 5 mL Lidocaine 0.5%
Infusion, Lidocaine, 0.5%, 10 mLDrug
Also called High dose
A catheter-based perineural infusion of 10 mL Lidocaine 0.5%
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Infusion, Lidocaine, 0.5%, 5 mL; Drug: Infusion, Lidocaine, 0.5%, 10 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of insensitivity towards cold
Time from nerve block onset time (T1) to nerve block remission (T2)
Measured: Up to 10 hours
Secondary outcomes (3)
Onset time
Time from infusion (T0) to onset (T1) of the nerve blocking effect
Measured: 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.
Measured: 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.
Measured: Up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start30 Oct 2017
- Primary completion1 Mar 2018
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, RegionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nordsjaellands Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Innovation Fund Denmark
- Responsible party
- Principal investigator, Mikkel Herold Madsen, Nordsjaellands Hospital
- Investigators
- Kai L Lange, MD, DMSci, Study director, Nordsjaellands Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03310047
- Sponsor's protocol ID
- Re_Injection
- Status last verified
- May 2018
- First submitted
- 7 Oct 2017
- Last updated
- 15 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-individual Reproducibility in Nerve Block Duration
- ClinicalTrials.gov ID
- NCT03310047
- Acronym / sponsor ID
- Re_Injection
- Conditions
- Anesthesia, Regional
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Nordsjaellands HospitalUniversity, hospital or other
- Collaborators
- Innovation Fund Denmark
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 16 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An interventional randomized controlled crossover trial, to illuminate if durations in nerve block durations are predictable within the same subject.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Right-low, left-high | Experimental | Drug: Infusion, Lidocaine, 0.5%, 5 mL, Drug: Infusion, Lidocaine, 0.5%, 10 mLThe 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. |
| Right-high, left-low | Experimental | Drug: Infusion, Lidocaine, 0.5%, 5 mL, Drug: Infusion, Lidocaine, 0.5%, 10 mLThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years
- ASA classification ≤ II
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infusion, Lidocaine, 0.5%, 5 mLAlso: Low doseA catheter-based perineural infusion of 5 mL Lidocaine 0.5% | Drug | Right-high, left-low, Right-low, left-high |
| Infusion, Lidocaine, 0.5%, 10 mLAlso: High doseA catheter-based perineural infusion of 10 mL Lidocaine 0.5% | Drug | Right-high, left-low, Right-low, left-high |
Primary outcome
Duration of insensitivity towards cold
Time frame: Up to 10 hours
Time from nerve block onset time (T1) to nerve block remission (T2)
3 secondary outcomes
Onset time
Time frame: Up to 30 minutes
Degree of sensory nerve block
Time frame: Up to 10 hours
Degree of motor nerve block
Time frame: Up to 10 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kai L Lange, MD, DMSci study director
Nordsjaellands Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Infusion, Lidocaine, 0.5%, 5 mL and Infusion, Lidocaine, 0.5%, 10 mL in people with Anesthesia, Regional, run by Nordsjaellands Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of insensitivity towards cold (time frame: Up to 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2018.