Muscle StrengthPhase 4NCT01981746
Adductor Canal Block and Effect of 10 Versus 30 ml Ropivacaine on Muscle Strength: a Randomized Study in Healthy Volunteers
A Phase 4 study testing Adductor canal block with ropivacaine 0.1% in people with Muscle Strength and Healthy Volunteers, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
To investigate whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce the number of subjects with impaired muscle strength following adductor canal block. We hypothesized that adductor canal block with 10 ml 0.1% ropivacaine preserves quadriceps strength compared with an adductor canal block… 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 block with ropivacaine 0.1%
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2013to Dec 2013
- 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
- 18-30 years
- Men
- ASA 1
- Body Mass Index 18-25
Who cannot join
- Allergy to study medication
- Earlier trauma or surgery to the lower limb
- Diabetes Mellitus
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
To investigate whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce the number of subjects with impaired muscle strength following adductor canal block. We hypothesized that adductor canal block with 10 ml 0.1% ropivacaine preserves quadriceps strength compared with an adductor canal block with 30 ml.
- Conditions
- Muscle Strength, Healthy Volunteers
- Being tested
- Adductor canal block with ropivacaine 0.1%
- Keywords
- adductor canal block, healthy volunteers, US-guided peripheral nerve block, lower limb
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adductor canal block with ropivacaine 0.1%Procedure or surgery
US-guided adductor canal block
| Study group | Role | What they receive |
|---|---|---|
| 30 ml | Experimental | 30 ml ropivacaine 0.1%, single bolus Receives: Procedure: Adductor canal block with ropivacaine 0.1% |
| 10 ml | Experimental | 10 ml 0.1% ropivacaine, single bolus Receives: Procedure: Adductor canal block with ropivacaine 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with reduced quadriceps strength
The difference between the two volumes in number of subjects experiencing a reduction in quadriceps muscle strength by more than 25% from baseline in two consecutive assessments.
Measured: 0.5 to 6 hours post block
Secondary outcomes (4)
Quadriceps strength in percentage of baseline
The difference between the two volumes in maximum voluntary isometric contraction (MVIC) of the quadriceps muscle, assessed as percentage of the baseline value.
Measured: 2, 3 and 4 hours post block
Quadriceps strength calculated as AUC
The difference between the two volumes in maximum voluntary isometric contraction (MVIC) of the quadriceps muscle calculated as "area under the curve" (AUC)
Measured: 30 minutes to 6 hours post block
Modified 30-second Chair Stand test
The difference between the pre block value and the post block value in the modified 30-second Chair Stand test performed on one leg, between the two volumes.
Measured: 2 and 4 hours post block
VAS pain scores during warmth stimulation
The difference between the two volumes in VAS pain score during warmth stimulation.
Measured: Mean value for the periode 30 minutes - 6 hours post block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 26 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, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981746
- Sponsor's protocol ID
- SM2-PJ-13
- Status last verified
- Jan 2014
- First submitted
- 5 Nov 2013
- Last updated
- 10 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jaeger P, Grevstad U, Koscielniak-Nielsen ZJ, Sauter AR, Sorensen JK, Dahl JB. Does dexamethasone have a perineural mechanism of action? A paired, blinded, randomized, controlled study in healthy volunteers. Br J Anaesth. 2016 Nov;117(5):635-641. doi: 10.1093/bja/aew318.
PubMed 27799178Jaeger P, Koscielniak-Nielsen ZJ, Hilsted KL, Fabritius ML, Dahl JB. Adductor Canal Block With 10 mL Versus 30 mL Local Anesthetics and Quadriceps Strength: A Paired, Blinded, Randomized Study in Healthy Volunteers. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):553-8. doi: 10.1097/AAP.0000000000000298.
PubMed 26237001
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Block and Effect of 10 Versus 30 ml Ropivacaine on Muscle Strength: a Randomized Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01981746
- Acronym / sponsor ID
- SM2-PJ-13
- Conditions
- Muscle Strength, Healthy Volunteers
- Keywords
- adductor canal block, healthy volunteers, US-guided peripheral nerve block, lower limb
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Nov 2013 (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.
To investigate whether reducing the volume (30 versus 10 ml) ropivacaine injected can reduce the number of subjects with impaired muscle strength following adductor canal block. We hypothesized that adductor canal block with 10 ml 0.1% ropivacaine preserves quadriceps strength compared with an adductor canal block with 30 ml.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 30 ml | Experimental | Procedure: Adductor canal block with ropivacaine 0.1%30 ml ropivacaine 0.1%, single bolus |
| 10 ml | Experimental | Procedure: Adductor canal block with ropivacaine 0.1%10 ml 0.1% ropivacaine, single bolus |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18-30 years
- Men
- ASA 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
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 ropivacaine 0.1%US-guided adductor canal block | Procedure or surgery | 10 ml, 30 ml |
Primary outcome
Number of subjects with reduced quadriceps strength
Time frame: 0.5 to 6 hours post block
The difference between the two volumes in number of subjects experiencing a reduction in quadriceps muscle strength by more than 25% from baseline in two consecutive assessments.
4 secondary outcomes
Quadriceps strength in percentage of baseline
Time frame: 2, 3 and 4 hours post block
Quadriceps strength calculated as AUC
Time frame: 30 minutes to 6 hours post block
Modified 30-second Chair Stand test
Time frame: 2 and 4 hours post block
VAS pain scores during warmth stimulation
Time frame: Mean value for the periode 30 minutes - 6 hours 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 10 Jan 2014.
- Derived from this study: PubMed 27799178Jaeger P, Grevstad U, Koscielniak-Nielsen ZJ, Sauter AR, Sorensen JK, Dahl JB. Does dexamethasone have a perineural mechanism of action? A paired, blinded, randomized, controlled study in healthy volunteers. Br J Anaesth. 2016 Nov;117(5):635-641. doi: 10.1093/bja/aew318.
- Derived from this study: PubMed 26237001Jaeger P, Koscielniak-Nielsen ZJ, Hilsted KL, Fabritius ML, Dahl JB. Adductor Canal Block With 10 mL Versus 30 mL Local Anesthetics and Quadriceps Strength: A Paired, Blinded, Randomized Study in Healthy Volunteers. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):553-8. doi: 10.1097/AAP.0000000000000298.
Related trials for Muscle Strength
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
Not yet recruitingObservational study
Isokinetic Knee Strength, Bilateral Muscle Balance, and Anaerobic Performance in Adolescent Athletes
Isokinetic Knee Strength, Hamstring-to-Quadriceps Strength Ratio
Recruiting
Effects of Urolithin A Supplementation on Glucose Metabolism in Healthy Adults 55 >= Years Old: A Randomized Triple-Masked Controlled Clinical Trial
Healthy Volunteer
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
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
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 block with ropivacaine 0.1% 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 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 10 Jan 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?
Number of subjects with reduced quadriceps strength (time frame: 0.5 to 6 hours 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 NCT01981746, which also lists 2 linked publications.
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 10 Jan 2014.