Quadriceps Muscle WeaknessPhase 4NCT01655277
Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block for Quadriceps Strength and Fall-risk
A Phase 4 study testing Ultrasound Guided Adductor Canal Block and Ultrasound Guided Femoral Nerve Block in people with Quadriceps Muscle Weakness and Adductor Muscle Weakness, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
Our objective was to determine if an ultrasound guided ACB can preserve quadriceps strength, thus minimizing weakness of knee extension compared with ultrasound guided femoral nerve block. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Quadriceps Muscle Weakness, Adductor Muscle Weakness, Fall Risk
- What is being tested?
- Ultrasound Guided Adductor Canal Block and Ultrasound Guided Femoral Nerve Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jun 2012
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults (>18yrs)
- ASA 1-2
Who cannot join
- BMI >30
- Allergy to local anesthetics
- Pre-existing gait disturbance
- Pre-existing neuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Roosevelt Hospital
New York, New York, 10025
About this study
Official title: The Effects of Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block on Quadriceps Strength and Fall-risk: a Blinded Randomized Trial of Volunteers
Our objective was to determine if an ultrasound guided ACB can preserve quadriceps strength, thus minimizing weakness of knee extension compared with ultrasound guided femoral nerve block. Our primary outcome was the percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 30 mins after either an ACB or FNB. Secondary outcomes included MVIC of knee extension at 60 min, hip adduction at 30 and 60 mins, and assessment of fall risk with the Berg Balance Scale (BBS) at 30 minutes.
- Being tested
- Ultrasound Guided Adductor Canal Block, Ultrasound Guided Femoral Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Adductor Canal BlockProcedure or surgery
Ultrasound Guided Femoral Nerve BlockProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Adductor Canal block first | Experimental | This arm received an ultrasound guided adductor canal block with 15mL of chloroprocaine 3% followed by motor, sensory and balance assessments. Then the patients received an ultrasound guided femoral nerve block with 15mL of chloroprocaine 3% followed by sensory and motor assessments. Receives: Procedure: Ultrasound Guided Adductor Canal Block; Procedure: Ultrasound Guided Femoral Nerve Block |
| Femoral nerve block first | Experimental | This arm received an ultrasound guided femoral nerve block with 15mL of chloroprocaine 3% followed by motor, sensory and balance assessments. Then the patients received an ultrasound guided adductor canal block with 15mL of chloroprocaine 3% followed by sensory and motor assessments. Receives: Procedure: Ultrasound Guided Adductor Canal Block; Procedure: Ultrasound Guided Femoral Nerve Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 30 mins after either an ACB or FNB
Measured: At 30 minutes
Secondary outcomes (4)
Percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 60 mins after either an ACB or FNB
Measured: At 60 minutes
Percent of maximum voluntary isometric contraction (MVIC) of hip adduction preserved at 30 mins after either an ACB or FNB
Measured: At 30 minutes
Percent of maximum voluntary isometric contraction (MVIC) of hip adduction preserved at 60 mins after either an ACB or FNB
Measured: At 60 minutes
Assessment of fall risk with the Berg Balance Scale (BBS) at 30 minutes after the first nerve block.
Measured: At 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2012 (estimated)
- Study startFeb 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quadriceps Muscle WeaknessStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Gadsden, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655277
- Sponsor's protocol ID
- 11-202
- Status last verified
- Jul 2012
- First submitted
- 30 Jul 2012
- Last updated
- 1 Aug 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Ultrasound Guided Adductor Canal Block Versus Femoral Nerve Block on Quadriceps Strength and Fall-risk: a Blinded Randomized Trial of Volunteers
- ClinicalTrials.gov ID
- NCT01655277
- Acronym / sponsor ID
- 11-202
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 Aug 2012 (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.
Our objective was to determine if an ultrasound guided ACB can preserve quadriceps strength, thus minimizing weakness of knee extension compared with ultrasound guided femoral nerve block. Our primary outcome was the percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 30 mins after either an ACB or FNB. Secondary outcomes included MVIC of knee extension at 60 min, hip adduction at 30 and 60 mins, and assessment of fall risk with the Berg Balance Scale (BBS) at 30 minutes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adductor Canal block first | Experimental | Procedure: Ultrasound Guided Adductor Canal Block, Procedure: Ultrasound Guided Femoral Nerve BlockThis arm received an ultrasound guided adductor canal block with 15mL of chloroprocaine 3% followed by motor, sensory and balance assessments. Then the patients received an ultrasound guided femoral nerve block with 15mL of chloroprocaine 3% followed by sensory and motor assessments. |
| Femoral nerve block first | Experimental | Procedure: Ultrasound Guided Adductor Canal Block, Procedure: Ultrasound Guided Femoral Nerve BlockThis arm received an ultrasound guided femoral nerve block with 15mL of chloroprocaine 3% followed by motor, sensory and balance assessments. Then the patients received an ultrasound guided adductor canal block with 15mL of chloroprocaine 3% followed by sensory and motor assessments. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (>18yrs)
- ASA 1-2
Key exclusion criteria (4 listed)
- BMI >30
- Allergy to local anesthetics
- Pre-existing gait disturbance
- Pre-existing neuropathy
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 |
|---|---|---|
| Ultrasound Guided Adductor Canal Block | Procedure or surgery | Adductor Canal block first, Femoral nerve block first |
| Ultrasound Guided Femoral Nerve Block | Procedure or surgery | Adductor Canal block first, Femoral nerve block first |
Primary outcome
Percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 30 mins after either an ACB or FNB
Time frame: At 30 minutes
4 secondary outcomes
Percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 60 mins after either an ACB or FNB
Time frame: At 60 minutes
Percent of maximum voluntary isometric contraction (MVIC) of hip adduction preserved at 30 mins after either an ACB or FNB
Time frame: At 30 minutes
Percent of maximum voluntary isometric contraction (MVIC) of hip adduction preserved at 60 mins after either an ACB or FNB
Time frame: At 60 minutes
Assessment of fall risk with the Berg Balance Scale (BBS) at 30 minutes after the first nerve block.
Time frame: At 30 minutes
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 1 Aug 2012.
Related trials for Quadriceps Muscle Weakness
Recruiting
Blood Flow Restriction Training in Knee Arthropathy
Knee Arthroscopic Surgery, Arthrogenic Muscle Inhibition
Not yet recruiting
Beyond Voluntary Effort: Reliability and Validity of Magnetic Femoral Nerve Stimulation for Assessing Quadriceps Strength in Critically Ill Patient
Critical Illness, ICU-acquired Weakness
RecruitingPhase 4
Low-Volume Pericapsular Nerve Group (PENG) Block With Dexamethasone vs Standard-Volume PENG Block After Total Hip Arthroplasty
Pain, Postoperative, Muscle Weakness
RecruitingObservational study
Quadriceps Muscle Activity and Gait Kinematics in Patients With Post-Stroke Stiff-Knee Gait Compared With Healthy Controls
Stroke, Hemiparesis
RecruitingObservational study
Early Assessment of Quadriceps Muscle Recovery by Dynamometry and 3D Ultrasound in Intensive Care Patients Under Invasive Mechanical Ventilation
Intensive Care Unit Acquired Weakness, Muscle Weakness
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Ultrasound Guided Adductor Canal Block and Ultrasound Guided Femoral Nerve Block in people with Quadriceps Muscle Weakness and Adductor Muscle Weakness, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
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 4 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 1 Aug 2012. 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 United States. 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?
Percent of maximum voluntary isometric contraction (MVIC) of knee extension preserved at 30 mins after either an ACB or FNB (time frame: At 30 minutes). 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 1 Aug 2012.