AzTrials
AzTrials

HealthyPhase 4NCT02172729

The Effect of Different Doses (Mass) of Local Anesthetic on Duration of Adductor Canal Block in Healthy Volunteers - Part 2

A Phase 4 study testing Adductor canal block with 20 ml lidocaine, single bolus in people with Healthy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

To investigate whether increased dose of local anesthetic (lidocaine) increases duration of peripheral nerve block (adductor canal block) and to develop a model for assessing duration of peripheral nerve blockades. Read more about this study

Who is it for?
Ages 18 to 30 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Adductor canal block with 20 ml lidocaine, single bolus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
1 siteDenmark
Study dates
Jun 2014to Jul 2014
Phase
Phase 4
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 to 30 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • ASA 1
  • Body mass index 18-25

Who cannot join

  • Allergy to study medication
  • Earlier trauma or surgery to lower limb
  • Diabetes Mellitus

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet, Centre of Head and Orthopaedics, Department of Anaesthesia

    Copenhagen, 2100

Other trials in Denmark

About this study

To investigate whether increased dose of local anesthetic (lidocaine) increases duration of peripheral nerve block (adductor canal block) and to develop a model for assessing duration of peripheral nerve blockades. The investigators hypothesize that increasing the dose of lidocaine (by increased concentration) will increase the duration of an adductor canal block.

The study is a follow up on an identical study (SM1-PJ-13, EudraCT number: 2013-001822-24 ) made earlier with different concentrations of lidocaine and a placebo group. For further information see trial registration at European Union Drug Regulatory Authorities Clinical Trial System.

Conditions
Healthy
Being tested
Adductor canal block with 20 ml lidocaine, single bolus
Keywords
adductor canal block, healthy volunteers, US-guided peripheral nerve block, lower limb, duration, Muscle Strength, Anesthetics, Local, Sensation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adductor canal block with 20 ml lidocaine, single bolusDrug

    Duration of an adductor canal block with 20 ml lidocaine, single bolus, administered as 5 or 15 mg/ml

Study groups in NCT02172729
Study groupRoleWhat they receive
ACB with lidocaine 5 mg/mlExperimentalAdductor canal block (ACB) with 20 ml lidocaine 5 mg/ml, single bolus
Receives: Drug: Adductor canal block with 20 ml lidocaine, single bolus
ACB with lidocaine 15 mg/mlExperimentalAdductor canal block with 20 ml lidocaine 15 mg/ml, single bolus
Receives: Drug: Adductor canal block with 20 ml lidocaine, single bolus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Duration of sensory block assessed with pinprick.

    Duration is defined as the time from block performance until recovery of sensation to pin-prick stimulus, assessed at 30 and 60 minutes post block, and thereafter every hour.

    Measured: 0-10 hours

Secondary outcomes (7)

  1. Duration of sensory block assessed by heat pain detection threshold

    Duration is defined as time from block performance until recovery of normal sensation (+/- 2 degrees Celsius from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour.

    Measured: 0-10 hours

  2. Duration of sensory block assessed by warmth detection threshold

    Duration is defined as time from block performance until recovery of normal sensation (return to baseline value + 2 degrees Celsius or less from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour.

    Measured: 0-10 hours

  3. Duration of sensory block assessed by pain during 1 minute of warmth stimulation

    Duration is defined as time from block performance until recovery of normal sensation (return to baseline VAS pain scores +/-10 mm from preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour.

    Measured: 0-10 hours

  4. Duration of sensory block assessed by tolerance to transcutaneal electrical stimulation

    Duration is defined as time from block performance until recovery of normal sensation (return to baseline preblock value) assessed at 30 and 60 minutes post block, and thereafter every hour.

    Measured: 0-10 hours

  5. Duration of sensory block assessed by cold sensation with an alcohol swab

    Duration is defined as time from block performance until recovery of normal sensation assessed at 30 and 60 minutes post block, and thereafter every hour.

    Measured: 0-10 hours

  6. Duration of motor block assessed as maximum voluntary isometric contraction.

    Duration is defined as time from block performance until recovery of normal muscle strength, assessed at 30 and 60 minutes post block, and thereafter every hour.

    Measured: 0-10 hours

  7. Time to onset of sensory block assessed by pinprick.

    Onset is defined as the time from block performance until loss of sensation to pin-prick stimulus assessed at 30 and 60 minutes post block, and thereafter every hour.

    Measured: 0-2 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionJul 2014
  4. Study completionJul 2014

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02172729
Sponsor's protocol ID
SM1-PJ-14
Other IDs
2014-001752-31, 2014
Status last verified
Nov 2014
First submitted
20 Jun 2014
Last updated
18 Nov 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Jaeger P, Koscielniak-Nielsen ZJ, Hilsted KL, Grevstad U, Siersma V, Fabritius ML, Dahl JB. Effect of Total Dose of Lidocaine on Duration of Adductor Canal Block, Assessed by Different Test Methods: A Report of Two Blinded, Randomized, Crossover Studies in Healthy Volunteers. Anesth Analg. 2016 Oct;123(4):1026-32. doi: 10.1213/ANE.0000000000001517.

    PubMed 27537926

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adductor canal block with 20 ml lidocaine, single bolus in people with Healthy, run by Copenhagen University Hospital, Rigshospitalet 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 3 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 18 Nov 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 sensory block assessed with pinprick. (time frame: 0-10 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02172729, which also lists 1 linked publication.

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 18 Nov 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in