Muscle StrengthPhase 4NCT01449097
Adductor-Canal-Blockade Versus the Femoral Nerve Block Effect on Muscle Strength and Mobilization in Healthy Volunteers
A Phase 4 study testing Adductor-Canal-Blockade and The femoral nerve block in people with Muscle Strength and Healthy Volunteers, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus the femoral nerve block versus placebo on muscle strength in healthy volunteers. The investigators hypothesize that the Adductor-Canal-Blockade results in a lesser reduction of the quadriceps muscle strength compared to the… 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
- Muscle Strength, Healthy Volunteers
- What is being tested?
- Adductor-Canal-Blockade and The femoral nerve block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2011to Nov 2011
- 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
- written informed consent
- ASA 1
- BMI > 18 og < 25
Who cannot join
- Can not cooperate to the exam
- Do not speak or understand Danish
- Drug allergy
- Alcohol or drug abuse
- Daily consumption of analgetics on prescription
- Any drug intake within the last 48 hours
Show all 11Show fewer
- Neuromuscular defects in the femoral nere, the obturator nerve or the muscles of the thigh.
- Previous surgery or trauma to the lower limb
- Diabetes Mellitus
- Intake of steroids, except steroids for inhalation
- Physical exercise within the last 24 hours prior to Day 1 and 2 of the study
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Anaesthesia, Centre of Head and Orthopaedics, Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100
About this study
Official title: Comparison of the Efficacy of the Adductor-Canal-Blockade Versus the Femoral Nerve Block on Muscle Strength and Mobilization in Healthy Volunteers: a Randomized Study
The aim of this study is to investigate the efficacy of the Adductor-Canal-Blockade versus the femoral nerve block versus placebo on muscle strength in healthy volunteers. The investigators hypothesize that the Adductor-Canal-Blockade results in a lesser reduction of the quadriceps muscle strength compared to the femoral nerve block.
- Conditions
- Muscle Strength, Healthy Volunteers
- Being tested
- Adductor-Canal-Blockade, The femoral nerve block, Placebo
- Keywords
- Adductor-Canal-blockade,, human volunteers,, US-guided nerve block, femoral nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor-Canal-BlockadeProcedure or surgery
US-guided Adductor-Canal-blockade with Ropivacaine
The femoral nerve blockProcedure or surgery
US-guided femoral nerve block with ropivacaine
PlaceboProcedure or surgery
US-guided Adductor-Canal-Blockade/femoral nerve block with saline
| Study group | Role | What they receive |
|---|---|---|
| Adductor-Canal-Blockade | Experimental | Not described Receives: Procedure: Adductor-Canal-Blockade |
| The femoral nerve block | Active comparator | Not described Receives: Procedure: The femoral nerve block |
| Placebo | Placebo comparator | Not described Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the difference in quadriceps muscle strength between the Adductor-Canal-Blockade and placebo
Measured: 0-6 hours
Secondary outcomes (4)
The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block
Measured: 0-6 hours
The difference in quadriceps muscle strength between the placebo and the femoral nerve block
Measured: 0-6 hours
The difference in adductor muscle strength between the groups
Measured: 0-6 hours
The difference in mobilization between the groups
Measured: 0-6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionNov 2011
- Study completionNov 2011
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 Muscle StrengthStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 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 Jæger, MD, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449097
- Sponsor's protocol ID
- SM2-PJ-11
- Status last verified
- Dec 2011
- First submitted
- 6 Oct 2011
- Last updated
- 22 Dec 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
PubMed 23241723
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficacy of the Adductor-Canal-Blockade Versus the Femoral Nerve Block on Muscle Strength and Mobilization in Healthy Volunteers: a Randomized Study
- ClinicalTrials.gov ID
- NCT01449097
- Acronym / sponsor ID
- SM2-PJ-11
- Conditions
- Muscle Strength, Healthy Volunteers
- Keywords
- Adductor-Canal-blockade,, human volunteers,, US-guided nerve block, femoral nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 7 Oct 2011 (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 study is to investigate the efficacy of the Adductor-Canal-Blockade versus the femoral nerve block versus placebo on muscle strength in healthy volunteers. The investigators hypothesize that the Adductor-Canal-Blockade results in a lesser reduction of the quadriceps muscle strength compared to the femoral nerve block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adductor-Canal-Blockade | Experimental | Procedure: Adductor-Canal-Blockade |
| The femoral nerve block | Active comparator | Procedure: The femoral nerve block |
| Placebo | Placebo comparator | Procedure: Placebo |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- written informed consent
- ASA 1
- BMI > 18 og < 25
Key exclusion criteria (11 listed)
- Can not cooperate to the exam
- Do not speak or understand Danish
- Drug allergy
- Alcohol or drug abuse
- Daily consumption of analgetics on prescription
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-BlockadeUS-guided Adductor-Canal-blockade with Ropivacaine | Procedure or surgery | Adductor-Canal-Blockade |
| The femoral nerve blockUS-guided femoral nerve block with ropivacaine | Procedure or surgery | The femoral nerve block |
| PlaceboUS-guided Adductor-Canal-Blockade/femoral nerve block with saline | Procedure or surgery | Placebo |
Primary outcome
the difference in quadriceps muscle strength between the Adductor-Canal-Blockade and placebo
Time frame: 0-6 hours
4 secondary outcomes
The difference in quadriceps muscle strength between the Adductor-Canal-Blockade and the femoral nerve block
Time frame: 0-6 hours
The difference in quadriceps muscle strength between the placebo and the femoral nerve block
Time frame: 0-6 hours
The difference in adductor muscle strength between the groups
Time frame: 0-6 hours
The difference in mobilization between the groups
Time frame: 0-6 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 22 Dec 2011.
- Derived from this study: PubMed 23241723Jaeger P, Nielsen ZJ, Henningsen MH, Hilsted KL, Mathiesen O, Dahl JB. Adductor canal block versus femoral nerve block and quadriceps strength: a randomized, double-blind, placebo-controlled, crossover study in healthy volunteers. Anesthesiology. 2013 Feb;118(2):409-15. doi: 10.1097/ALN.0b013e318279fa0b.
Related trials for Muscle Strength
Recruiting
Effects of Dietary Supplements on Muscle Mass and Function While Using GLP-1 Medication
Obesity & Overweight, Muscle Mass and Strength
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Enrolling by invitation
Omega-3 Fatty Acids and Muscle Strength
Muscle Strength, Cognitive Function Assessment
Not yet recruiting
Effect of HMB Supplementation and Vivifrail Exercise on Body Composition, Handgrip Strength and Physical Performance in Women Over 60 Years of Age
Aging, Muscle Strength
Not yet recruitingObservational study
Associations of Respiratory Muscle Strength and Trunk Muscle Mechanical Properties With Dynamic Postural Control
Postural Control, Muscle Tonus
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 Jæger, MD principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adductor-Canal-Blockade and The femoral nerve block in people with Muscle Strength and Healthy Volunteers, 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 3 inclusion and 11 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 22 Dec 2011. 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. Some participants in this study may receive a placebo. 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?
the difference in quadriceps muscle strength between the Adductor-Canal-Blockade and placebo (time frame: 0-6 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 NCT01449097, 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 22 Dec 2011; AzTrials last refreshed its copy on 8 Nov 2026.