HealthyPhase 2NCT02033356
ED95 of Lidocaine 1.0% for Filling the Adductor Canal
A Phase 2 study testing Adductor canal block with lidocaine 1% and Lidocaine in people with Healthy, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of this prospective dose finding study is to estimate the minimal effective volume (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal block. Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Adductor canal block with lidocaine 1% and Lidocaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2014to Feb 2014
- Phase
- Phase 2
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-30 years
- Men
- American Society of Anesthesiologists' class 1
- Body Mass Index 18-25
Who cannot join
- Allergy to study medication
- Earlier trauma or surgery to the lower limb
- Diabetes Mellitus - Contraindications to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Estimate of the ED95 of Lidocaine 1.0% for Filling the Adductor Canal When Placing an Adductor Canal Block in Healthy Volunteers
The aim of this prospective dose finding study is to estimate the minimal effective volume (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal block. We will apply the Continual Reassessment Method (CRM) for estimating the ED95 and use an MRI scan to evaluate the main objective and ensure spread to the distal part of the adductor canal.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor canal block with lidocaine 1%Procedure or surgery
US-guided adductor canal block
LidocaineDrug
| Study group | Role | What they receive |
|---|---|---|
| ACB with 30 ml lidocaine 1% | Experimental | Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. Receives: Procedure: Adductor canal block with lidocaine 1%; Drug: Lidocaine |
| ACB with 25 ml lidocaine 1% | Experimental | Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. Receives: Procedure: Adductor canal block with lidocaine 1%; Drug: Lidocaine |
| ACB with 20 ml lidocaine 1% | Experimental | Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. Receives: Procedure: Adductor canal block with lidocaine 1%; Drug: Lidocaine |
| ACB with 15 ml lidocaine 1% | Experimental | Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. Receives: Procedure: Adductor canal block with lidocaine 1%; Drug: Lidocaine |
| ACB with 10 ml lidocaine 1% | Experimental | Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. Receives: Procedure: Adductor canal block with lidocaine 1%; Drug: Lidocaine |
| ACB with 5 ml lidocaine 1% | Experimental | Procedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study.
Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. Receives: Procedure: Adductor canal block with lidocaine 1%; Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the ED 95 for the volume needed to fill the adductor canal distally.
This will be evaluated as a binary outcome using MRI; where the adductor canal is considered to be filled if the lidocaine injectate can be identified inside the canal in the first slice distally to the insertion of the adductor longus muscle on femur.
Measured: MRI performed 15 minutes post block
Secondary outcomes (4)
To investigate the effect of volume on proximal spread to the femoral triangle
Evaluated as a binary outcome using MRI
Measured: MRI performed 15 minutes post block
Quadriceps muscle strength
To investigate the effect of volume on quadriceps muscle strength, assessed as maximum voluntary isometric contraction (MVIC) and evaluated as a binary outcome (reduction by more or less than 25%).
Measured: 1 hour post block
Pin prick test
To investigate the effect of volume on sensory block assessed by pin-prick in the saphenous innervation area and in the popliteal fossa.
Measured: 1 hour post block
Temperature discrimination test
To investigate the effect of volume on sensory block assessed by cold sensation using alchohol swabs, in the saphenous innervation area and in the popliteal fossa.
Measured: 1 hour post block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia Jaeger, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Pia Jaeger, MD, Principal investigator, Department of Anaesthesia, HOC, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033356
- Sponsor's protocol ID
- SM3-PJ-13
- Other IDs
- 2013-004462-33
- Status last verified
- Apr 2014
- First submitted
- 9 Jan 2014
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jaeger P, Jenstrup MT, Lund J, Siersma V, Brondum V, Hilsted KL, Dahl JB. Optimal volume of local anaesthetic for adductor canal block: using the continual reassessment method to estimate ED95. Br J Anaesth. 2015 Dec;115(6):920-6. doi: 10.1093/bja/aev362.
PubMed 26582853
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Estimate of the ED95 of Lidocaine 1.0% for Filling the Adductor Canal When Placing an Adductor Canal Block in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02033356
- Acronym / sponsor ID
- SM3-PJ-13
- Conditions
- Healthy
- Keywords
- adductor canal block, volunteers, US-guided peripheral nerve block, lower limb, MRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Jan 2014 (estimated)
- 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.
The aim of this prospective dose finding study is to estimate the minimal effective volume (ED95) for lidocaine 1.0% for filling the adductor canal when placing an adductor canal block. We will apply the Continual Reassessment Method (CRM) for estimating the ED95 and use an MRI scan to evaluate the main objective and ensure spread to the distal part of the adductor canal.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| ACB with 30 ml lidocaine 1% | Experimental | Procedure: Adductor canal block with lidocaine 1%, Drug: LidocaineProcedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. |
| ACB with 25 ml lidocaine 1% | Experimental | Procedure: Adductor canal block with lidocaine 1%, Drug: LidocaineProcedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. |
| ACB with 20 ml lidocaine 1% | Experimental | Procedure: Adductor canal block with lidocaine 1%, Drug: LidocaineProcedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. |
| ACB with 15 ml lidocaine 1% | Experimental | Procedure: Adductor canal block with lidocaine 1%, Drug: LidocaineProcedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. |
| ACB with 10 ml lidocaine 1% | Experimental | Procedure: Adductor canal block with lidocaine 1%, Drug: LidocaineProcedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. |
| ACB with 5 ml lidocaine 1% | Experimental | Procedure: Adductor canal block with lidocaine 1%, Drug: LidocaineProcedure/Surgery: Adductor canal block with lidocaine 1% The Continual Reassessment Method is used to calculate the dose level consecutively for every new cohort (2 subjects) in the study. Possible dose levels are: 5, 10, 15, 20, 25 and 30 ml. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-30 years
- Men
- American Society of Anesthesiologists' class 1
- Body Mass Index 18-25
Key exclusion criteria (3 listed)
- Allergy to study medication
- Earlier trauma or surgery to the lower limb
- Diabetes Mellitus - Contraindications to MRI
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 |
|---|---|---|
| Adductor canal block with lidocaine 1%US-guided adductor canal block | Procedure or surgery | ACB with 10 ml lidocaine 1%, ACB with 15 ml lidocaine 1%, ACB with 20 ml lidocaine 1%, ACB with 25 ml lidocaine 1%, ACB with 30 ml lidocaine 1%, ACB with 5 ml lidocaine 1% |
| Lidocaine | Drug | ACB with 10 ml lidocaine 1%, ACB with 15 ml lidocaine 1%, ACB with 20 ml lidocaine 1%, ACB with 25 ml lidocaine 1%, ACB with 30 ml lidocaine 1%, ACB with 5 ml lidocaine 1% |
Primary outcome
To estimate the ED 95 for the volume needed to fill the adductor canal distally.
Time frame: MRI performed 15 minutes post block
This will be evaluated as a binary outcome using MRI; where the adductor canal is considered to be filled if the lidocaine injectate can be identified inside the canal in the first slice distally to the insertion of the adductor longus muscle on femur.
4 secondary outcomes
To investigate the effect of volume on proximal spread to the femoral triangle
Time frame: MRI performed 15 minutes post block
Quadriceps muscle strength
Time frame: 1 hour post block
Pin prick test
Time frame: 1 hour post block
Temperature discrimination test
Time frame: 1 hour post block
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 4 Apr 2014.
- Derived from this study: PubMed 26582853Jaeger P, Jenstrup MT, Lund J, Siersma V, Brondum V, Hilsted KL, Dahl JB. Optimal volume of local anaesthetic for adductor canal block: using the continual reassessment method to estimate ED95. Br J Anaesth. 2015 Dec;115(6):920-6. doi: 10.1093/bja/aev362.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Pia Jaeger, MD principal investigator
Department of Anaesthesia, HOC, Rigshospitalet, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adductor canal block with lidocaine 1% and Lidocaine 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 4 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 4 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To estimate the ED 95 for the volume needed to fill the adductor canal distally. (time frame: MRI performed 15 minutes post block). 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 NCT02033356, 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 4 Apr 2014.