Knee Replacement ArthroplastyPhase 4NCT02242591
Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain After Total Knee Arthroplasty
A Phase 4 study testing Ropivacaine 7,5 mg/ml and Saline in people with Knee Replacement Arthroplasty, run by Ulrik Grevstad at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the effect of adductor canal block (ACB) vs. placebo on muscle strength, mobility and pain on the first postoperative day after total knee alloplastic (TKA). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Knee Replacement Arthroplasty
- What is being tested?
- Ropivacaine 7,5 mg/ml and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2014to Nov 2014
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have had a Total Knee Arthroplasty surgery within 2 days (1.postoperative day on inclusion)
- Written informed consent.
- ASA 1-3
Who cannot join
- Non-cooperative patients
- Patients who have already had a peripheral or central block post surgery.
- Patients who are not able to perform a TUG test pre surgery.
- Patients who do not understand or speak Danish.
- Patient who are allergic to the drugs used in this research.
- Patients with alcohol- or drug abuse - determined by investigator.
- Patients with peripheral sensory neuropathy in their lower extremities.
- Pregnant patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain on the First Post-operative Day After Total Knee Arthroplasty
The purpose of this study is to evaluate the effect of adductor canal block (ACB) vs. placebo on muscle strength, mobility and pain on the first postoperative day after total knee alloplastic (TKA).
Read the detailed description
Patients will be included on the first day after TKA surgery and randomized in two groups. Each group will receive 2 ACB with a 1 hour interval, one ACB with an active drug, Ropivacaine, and another ACB with a placebo drug, Saline.
At T0, arm ACB_active/placebo will receive the active ACB with Ropivacaine followed by the placebo ACB at T60 (60 minutes after T0).
At T0, arm ACB_placebo/active will receive the placebo ACB with Saline followed by the active ACB with Ropivacaine at T60 (60 minutes after T0).
Outcome measurements will be made at T60, 1 hour after the first ACB, and the difference in outcome between the groups will be compared.
Baseline values will be measured prior to the first ACB. Final measurements at T120 (120 minutes after the initial ACB), will determine if the differences between the groups are eliminated, since both groups then have received an active ACB.
- Conditions
- Knee Replacement Arthroplasty
- Being tested
- Ropivacaine 7,5 mg/ml, Saline
- Keywords
- Knee surgery, Saphenous nerve, Perineural block, Adductor Canal Block, Postoperative Pain, Mobilization
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 7,5 mg/mlDrug
Also called Product name: Ropivacain "Fresenius Kabi", Ropivacainhydrochloridmonohydrat, Importet to Denmark by Fresenius Kabi AB, Injection mixture
SalineDrug
Also called Product name: Natriumklorid "Fresenius Kabi" 9 mg/ml, Sodium 9g/l, Electrolyte content: Na+ 154 mmol/l, Cl- 154 mmol/l
| Study group | Role | What they receive |
|---|---|---|
| ACB_active/placebo | Active comparator | Patients will receive the first ACB with a active drug, 30 ml bolus Ropivacaine 7,5 mg/ml at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60 (60 minutes after T0), patients will receive their second ACB with the placebo drug, 30 ml bolus Saline and outcome measures performed again at T120(120 minutes after T0).
The measurements for baseline and outcome will be made in following order:
VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test Receives: Drug: Ropivacaine 7,5 mg/ml; Drug: Saline |
| ACB_placebo/active | Placebo comparator | Patients will receive the first ACB with placebo, 30 ml isotonic saline at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60(60 minutes after T0), patients will receive their second ACB with the ropivacaine 7,5 mg/ml 30 ml and outcome measures performed again at T120(120 minutes after T0).
The measurements for baseline and outcome will be made in following order:
VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test Receives: Drug: Ropivacaine 7,5 mg/ml; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference between groups in muscle strength of the quadriceps femoris muscle.
Muscle strength is assessed as maximum voluntary isometric contraction (MVIC) using a hand-held dynamometer.3 consecutive measurements will be made and the average used. Results for each group will be presented as percentage of baseline values. The primary outcome is the difference in MVIC between the groups.
Measured: 60 minutes after first ACB (T60)
Secondary outcomes (6)
Difference between groups in muscle strength of the quadriceps femoris muscle.
Same as primary outcome
Measured: 120 minutes after initial ACB (T120)
VAS pain scores at rest
Pain at rest (VAS 0-100 mm) one hour after the first and second ACB. Results will be compared between the two groups.
VAS pain scores at rest will be inquired before any other outcome measurements.
Measured: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)
VAS pain score during TUG test.
Highest VAS (0-100 mm) pain score during TUG test will be inquired for each TUG test. Results will be compared between the two groups.
Measured: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
Timed Up and Go(TUG) test
Time (seconds) to complete a TUG test measured one hour after the first and second ACB. Results will be compared between the two groups.
Measured: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
VAS pain scores during 45 degrees active flexion of the knee
Specification of pain (VAS 0-100 mm) during 45 degrees active flexion of the knee one hour after first and second ACB. Results will be compared between the two groups.
Measured: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
Sub-group analysis of muscle strength and mobility acconding to baseline VAS during active flexion of the knee prior to the first block
According to their specified VAS (0-100 mm) pain score during active flexion of the knee prior to the first block, patients will be divided into two groups. Group 1 VAS 0-59 mm and group 2 with VAS 60-100 mm. Results within the two groups will be compared: e.g is there a difference in MVIC in the subgroup of patients scoring VAS 0-59 during active knee flexion at baseline? and is this difference larger in the subgroup of patients scoring VAS 60-100?
Measured: 60 minutes after first ACB (T60)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2014 (estimated)
- Study startAug 2014
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Replacement ArthroplastyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 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
- NCT02242591
- Sponsor's protocol ID
- 2014-002245-21
- Other IDs
- 2014
- Status last verified
- Nov 2014
- First submitted
- 12 Sep 2014
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain on the First Post-operative Day After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02242591
- Acronym / sponsor ID
- 2014-002245-21
- Conditions
- Knee Replacement Arthroplasty
- Keywords
- Knee surgery, Saphenous nerve, Perineural block, Adductor Canal Block, Postoperative Pain, Mobilization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Ulrik GrevstadUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 17 Sep 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 purpose of this study is to evaluate the effect of adductor canal block (ACB) vs. placebo on muscle strength, mobility and pain on the first postoperative day after total knee alloplastic (TKA).
Detailed description
Patients will be included on the first day after TKA surgery and randomized in two groups. Each group will receive 2 ACB with a 1 hour interval, one ACB with an active drug, Ropivacaine, and another ACB with a placebo drug, Saline.
At T0, arm ACB_active/placebo will receive the active ACB with Ropivacaine followed by the placebo ACB at T60 (60 minutes after T0).
At T0, arm ACB_placebo/active will receive the placebo ACB with Saline followed by the active ACB with Ropivacaine at T60 (60 minutes after T0).
Outcome measurements will be made at T60, 1 hour after the first ACB, and the difference in outcome between the groups will be compared.
Baseline values will be measured prior to the first ACB. Final measurements at T120 (120 minutes after the initial ACB), will determine if the differences between the groups are eliminated, since both groups then have received an active ACB.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACB_active/placebo | Active comparator | Drug: Ropivacaine 7,5 mg/ml, Drug: SalinePatients will receive the first ACB with a active drug, 30 ml bolus Ropivacaine 7,5 mg/ml at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60 (60 minutes after T0), patients will receive their second ACB with the placebo drug, 30 ml bolus Saline and outcome measures performed again at T120(120 minutes after T0). The measurements for baseline and outcome will be made in following order: VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test |
| ACB_placebo/active | Placebo comparator | Drug: Ropivacaine 7,5 mg/ml, Drug: SalinePatients will receive the first ACB with placebo, 30 ml isotonic saline at T0. First outcome measurement are made one hour after the first ACB, prior to their second ACB. At T60(60 minutes after T0), patients will receive their second ACB with the ropivacaine 7,5 mg/ml 30 ml and outcome measures performed again at T120(120 minutes after T0). The measurements for baseline and outcome will be made in following order: VAS pain score at rest - VAS pain score during active flexion of the knee - Muscle strength - TUG test - Highest VAS pain score during TUG test |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have had a Total Knee Arthroplasty surgery within 2 days (1.postoperative day on inclusion)
- Written informed consent.
- ASA 1-3
Key exclusion criteria (8 listed)
- Non-cooperative patients
- Patients who have already had a peripheral or central block post surgery.
- Patients who are not able to perform a TUG test pre surgery.
- Patients who do not understand or speak Danish.
- Patient who are allergic to the drugs used in this research.
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 |
|---|---|---|
| Ropivacaine 7,5 mg/mlAlso: Product name: Ropivacain "Fresenius Kabi", Ropivacainhydrochloridmonohydrat, Importet to Denmark by Fresenius Kabi AB, Injection mixture | Drug | ACB_active/placebo, ACB_placebo/active |
| SalineAlso: Product name: Natriumklorid "Fresenius Kabi" 9 mg/ml, Sodium 9g/l, Electrolyte content: Na+ 154 mmol/l, Cl- 154 mmol/l | Drug | ACB_active/placebo, ACB_placebo/active |
Primary outcome
Difference between groups in muscle strength of the quadriceps femoris muscle.
Time frame: 60 minutes after first ACB (T60)
Muscle strength is assessed as maximum voluntary isometric contraction (MVIC) using a hand-held dynamometer.3 consecutive measurements will be made and the average used. Results for each group will be presented as percentage of baseline values. The primary outcome is the difference in MVIC between the groups.
6 secondary outcomes
Difference between groups in muscle strength of the quadriceps femoris muscle.
Time frame: 120 minutes after initial ACB (T120)
VAS pain scores at rest
Time frame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120)
VAS pain score during TUG test.
Time frame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
Timed Up and Go(TUG) test
Time frame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
VAS pain scores during 45 degrees active flexion of the knee
Time frame: 60 minutes after the initial ACB (T60) and 120 minutes after initial ACB (T120
Sub-group analysis of muscle strength and mobility acconding to baseline VAS during active flexion of the knee prior to the first block
Time frame: 60 minutes after first ACB (T60)
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 2 Dec 2014.
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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 Ropivacaine 7,5 mg/ml and Saline in people with Knee Replacement Arthroplasty, 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 3 inclusion and 8 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 2 Dec 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. 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 groups in muscle strength of the quadriceps femoris muscle. (time frame: 60 minutes after first ACB (T60)). 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 2 Dec 2014.