Knee Arthroplasty, TotalPhase 4NCT02344589
The Effect of Local Anesthetic Volume Within the Adductor Canal on Quadriceps Function Evaluated by Electromyography
A Phase 4 study testing Lidocaine and Saline in people with Knee Arthroplasty, Total, run by Ulrik Grevstad at 1 site in Denmark.
Trial summary
Our aim is to investigate which components of the quadriceps femoris muscle are affected following an ACB with different volumes (10, 20 and 30 ml) of 1% lignocaine evaluated by electromyography. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Knee Arthroplasty, Total
- What is being tested?
- Lidocaine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Jan 2015
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Subjects who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and re-strictions.
- ASA 1
- Male
- BMI 18-30
- Physical exercise 1-3 hours/week
Who cannot join
- Subjects who cannot cooperate with the study.
- Subjects who cannot understand or speak Danish.
- Subjects with allergy to the medicines used in the study.
- Subjects suffering from alcohol and/or drug abuse - based on the investi-gator's opinion.
- Pathology or previous surgery or trauma to the lower limb.
- Intense exercise 24 h before the tests
- Intake of any analgesics 24 h prior to baseline measurements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Local Anesthetic Volume Within the Adductor Canal on Quadriceps Function Evaluated by Electromyography: A Randomized, Observer-Masked, Placebo-Controlled Study in Volunteers.
Our aim is to investigate which components of the quadriceps femoris muscle are affected following an ACB with different volumes (10, 20 and 30 ml) of 1% lignocaine evaluated by electromyography. Both a placebo treatment (20ml saline) and the femoral nerve block (20ml lignocaine 1%) as an active comparative will be used for model control. Further, we want to investigate the effect of volume on motor block. This will be evaluated by measuring the Maximum Voluntary Isometric Contraction (MVIC) of the quadriceps femoris muscle.
Read the detailed description
The ACB has a well-proven analgesic effect after TKA, but we do not know which nerves that are affected by the block. Aside being a motor nerve, the nerve to the vastus medialis of the quadriceps femoris muscle, contains the second largest sensory contribution from the femoral nerve. It is probable that some of the analgesic effect of the ACB arises from blocking this nerve.
Even though the ACB is mainly a sensory nerve block, a study in healthy volunteers showed a small decline by 8% in quadriceps muscle strength(10). It is speculated that the decline in muscle strength was caused by the spread of local anesthetic to the nerve supplying the vastus medialis of the quadriceps femoris muscle. Three out of eleven of the volunteers experienced an even larger decline of 25 % in quadriceps muscle strength. It has been argued that this decline likely was caused by a proximal spread of the local anesthetic to the femoral triangle thereby resulting in an affection of the femoral nerve. In this study, a volume of 30 ml of local anesthetic was used.
We do not know the optimal volume for the ACB and we find it relevant to investigate to what extent and which parts of the quadriceps muscle gets affected when different volumes of a local anesthetic are injected into the adductor canal. Selective affection of the different components of the femoral quadriceps muscle can be assessed by non-invasive EMG recordings. Further, the quadriceps femoris muscle strength will be evaluated by measuring the MVIC following the different volumes. The EMG recordings will be voluntary (vEMG) measured during MVIC and stimulated (sEMG). sEMG is measured during transcutaneous electrical stimulation of the femoral nerve.
- Conditions
- Knee Arthroplasty, Total
- Being tested
- Lidocaine, Saline
- Keywords
- ACB, Adductor Canal Block, Peripheral Nerve Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Also called lignocaine
used for the active blocks
SalineDrug
Also called NaCl
used for the placebo-block
| Study group | Role | What they receive |
|---|---|---|
| ACB 10 | Experimental | ACB in right leg with 10ml of lidocaine 10mg/ml. Subject and assessor blinded, randomized. given on day 1, 2 or 3 Receives: Drug: Lidocaine |
| ACB 20 | Experimental | ACB in right leg with 20ml of lidocaine 10mg/ml. Subject and assessor blinded, randomized. given on day 1, 2 or 3 Receives: Drug: Lidocaine |
| ACB 30 | Experimental | ACB in right leg with 30ml of lidocaine 10mg/ml. Subject and assessor blinded, randomized. given on day 1, 2 or 3 Receives: Drug: Lidocaine |
| FNB | Active comparator | FNB in left leg with 20ml of lidocaine 10mg/ml on day 1. Unblinded arm, used for model control Receives: Drug: Lidocaine |
| Placebo | Placebo comparator | ACB in left leg with 30ml of isotonic saline on day 2. Unblinded arm used for model control Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between ACB-groups, one hour post-block, in amplitude of the rectified vEMG signal from the vastus medialis, expressed as percentage of the pre-block value.
vEMG=voluntary electromyography
Measured: one hour post-block
Secondary outcomes (6)
• Difference between ACB-groups, one hour post-block, in amplitude of the rectified vEMG signal from the vastus lateralis, expressed as percentage of the pre-block value.
vEMG=voluntary electromyography
Measured: one hour post block
• Difference between groups, one hour post-block, in MVIC expressed as percentage of the pre-block value
MVIC=maximum voluntary isometric contraction. (Quadriceps femoris muscle)
Measured: one hour post-block
• Difference between ACB-groups, one hour post-block, in amplitude of the rectified sEMG signal from the vastus medialis, expressed as percentage of the pre-block value.
sEMG= stimulated Electromyography
Measured: one hour post-block
• Difference between ACB-groups, one hour post-block, in amplitude of the rectified sEMG signal from the vastus lateralis, expressed as percentage of the pre-block value.
sEMG= stimulated Electromyography
Measured: one hour post-block
• Association between volume and MVIC. MVIC expressed as a percentage of the pre-block value.
Measured: one hour post-block
Difference in proportions between ACB-groups having an affection of both the saphenous nerve and the vastus medialis (but no other components of the quadriceps femoris muscle), one hour post block evaluated by EMG
For each subject a series of 5 voluntary EMG recordings during MVIC will be made to estab-lish the variability of the EMG recordings. This will be done prior to the blocks on each day resulting in 300 EMG recordings from the vastus medialis and 300 recordings from the vastus lateralis. From this variability we will establish a cut-off point (how large a decline in EMG amplitude is "synonymous" with affection of the nerve?). After the cut-off point has been established the EMG data will be presented in dichotomous form: affected/not affected
Measured: one 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 posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Arthroplasty, TotalStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ulrik Grevstad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ulrik Grevstad, University Hospital, Gentofte, Copenhagen
- Investigators
- Ulrik Grevstad, MD, Principal investigator, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344589
- Sponsor's protocol ID
- SM-UG-14
- Status last verified
- Jan 2015
- First submitted
- 16 Jan 2015
- Last updated
- 29 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Local Anesthetic Volume Within the Adductor Canal on Quadriceps Function Evaluated by Electromyography: A Randomized, Observer-Masked, Placebo-Controlled Study in Volunteers.
- ClinicalTrials.gov ID
- NCT02344589
- Acronym / sponsor ID
- SM-UG-14
- Conditions
- Knee Arthroplasty, Total
- Keywords
- ACB, Adductor Canal Block, Peripheral Nerve Block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ulrik GrevstadUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Jan 2015 (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 aim is to investigate which components of the quadriceps femoris muscle are affected following an ACB with different volumes (10, 20 and 30 ml) of 1% lignocaine evaluated by electromyography. Both a placebo treatment (20ml saline) and the femoral nerve block (20ml lignocaine 1%) as an active comparative will be used for model control. Further, we want to investigate the effect of volume on motor block. This will be evaluated by measuring the Maximum Voluntary Isometric Contraction (MVIC) of the quadriceps femoris muscle.
Detailed description
The ACB has a well-proven analgesic effect after TKA, but we do not know which nerves that are affected by the block. Aside being a motor nerve, the nerve to the vastus medialis of the quadriceps femoris muscle, contains the second largest sensory contribution from the femoral nerve. It is probable that some of the analgesic effect of the ACB arises from blocking this nerve.
Even though the ACB is mainly a sensory nerve block, a study in healthy volunteers showed a small decline by 8% in quadriceps muscle strength(10). It is speculated that the decline in muscle strength was caused by the spread of local anesthetic to the nerve supplying the vastus medialis of the quadriceps femoris muscle. Three out of eleven of the volunteers experienced an even larger decline of 25 % in quadriceps muscle strength. It has been argued that this decline likely was caused by a proximal spread of the local anesthetic to the femoral triangle thereby resulting in an affection of the femoral nerve. In this study, a volume of 30 ml of local anesthetic was used.
We do not know the optimal volume for the ACB and we find it relevant to investigate to what extent and which parts of the quadriceps muscle gets affected when different volumes of a local anesthetic are injected into the adductor canal. Selective affection of the different components of the femoral quadriceps muscle can be assessed by non-invasive EMG recordings. Further, the quadriceps femoris muscle strength will be evaluated by measuring the MVIC following the different volumes. The EMG recordings will be voluntary (vEMG) measured during MVIC and stimulated (sEMG). sEMG is measured during transcutaneous electrical stimulation of the femoral nerve.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ACB 10 | Experimental | Drug: LidocaineACB in right leg with 10ml of lidocaine 10mg/ml. Subject and assessor blinded, randomized. given on day 1, 2 or 3 |
| ACB 20 | Experimental | Drug: LidocaineACB in right leg with 20ml of lidocaine 10mg/ml. Subject and assessor blinded, randomized. given on day 1, 2 or 3 |
| ACB 30 | Experimental | Drug: LidocaineACB in right leg with 30ml of lidocaine 10mg/ml. Subject and assessor blinded, randomized. given on day 1, 2 or 3 |
| FNB | Active comparator | Drug: LidocaineFNB in left leg with 20ml of lidocaine 10mg/ml on day 1. Unblinded arm, used for model control |
| Placebo | Placebo comparator | Drug: SalineACB in left leg with 30ml of isotonic saline on day 2. Unblinded arm used for model control |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years old
- Subjects who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and re-strictions.
- ASA 1
- Male
- BMI 18-30
Key exclusion criteria (7 listed)
- Subjects who cannot cooperate with the study.
- Subjects who cannot understand or speak Danish.
- Subjects with allergy to the medicines used in the study.
- Subjects suffering from alcohol and/or drug abuse - based on the investi-gator's opinion.
- Pathology or previous surgery or trauma to the lower limb.
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 |
|---|---|---|
| LidocaineAlso: lignocaineused for the active blocks | Drug | ACB 10, ACB 20, ACB 30, FNB |
| SalineAlso: NaClused for the placebo-block | Drug | Placebo |
Primary outcome
Difference between ACB-groups, one hour post-block, in amplitude of the rectified vEMG signal from the vastus medialis, expressed as percentage of the pre-block value.
Time frame: one hour post-block
vEMG=voluntary electromyography
6 secondary outcomes
• Difference between ACB-groups, one hour post-block, in amplitude of the rectified vEMG signal from the vastus lateralis, expressed as percentage of the pre-block value.
Time frame: one hour post block
• Difference between groups, one hour post-block, in MVIC expressed as percentage of the pre-block value
Time frame: one hour post-block
• Difference between ACB-groups, one hour post-block, in amplitude of the rectified sEMG signal from the vastus medialis, expressed as percentage of the pre-block value.
Time frame: one hour post-block
• Difference between ACB-groups, one hour post-block, in amplitude of the rectified sEMG signal from the vastus lateralis, expressed as percentage of the pre-block value.
Time frame: one hour post-block
• Association between volume and MVIC. MVIC expressed as a percentage of the pre-block value.
Time frame: one hour post-block
Difference in proportions between ACB-groups having an affection of both the saphenous nerve and the vastus medialis (but no other components of the quadriceps femoris muscle), one hour post block evaluated by EMG
Time frame: one 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 29 Jan 2015.
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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.
Ulrik Grevstad, MD principal investigator
Gentofte Hospital
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 Lidocaine and Saline in people with Knee Arthroplasty, Total, run by Ulrik Grevstad 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 6 inclusion and 7 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 29 Jan 2015. 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?
Difference between ACB-groups, one hour post-block, in amplitude of the rectified vEMG signal from the vastus medialis, expressed as percentage of the pre-block value. (time frame: one hour post-block). 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 29 Jan 2015.