Pain After Total Knee ArthroplastyPhase 4NCT01549704
Effect of Adductor-Canal-Blockade on High Pain Responders After Total Knee Arthroplasty
A Phase 4 study testing Ropivacaine and Saline in people with Pain After Total Knee Arthroplasty, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior to placebo when it comes to analgetic efficacy in high pain responders after Total Knee Arthroplasty (TKA). High pain responders are defined as patients reporting VAS > 60 during knee flexion the 1. or 2. day after surgery. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Pain After Total Knee Arthroplasty
- What is being tested?
- Ropivacaine and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2012to Dec 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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TKA within 48 hours and VAS>60 during active 45 degrees knee flexion despite conventional pain medication.
- Informed consent
- ASA 1-3
- BMI 18-40
Who cannot join
- Unable to communicate in Danish
- Allergic reactions toward drugs used in the
- Abuse of alcohol/drugs
- Unable to cooperate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Adductor-Canal-Blockade on High Pain Responders the 1. or 2. Postoperative Day After Total Knee Arthroplasty
The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior to placebo when it comes to analgetic efficacy in high pain responders after Total Knee Arthroplasty (TKA). High pain responders are defined as patients reporting VAS > 60 during knee flexion the 1. or 2. day after surgery.
Read the detailed description
The patients will be included the 1. or 2. day after surgery. All TKA patients will be screened. Those reporting VAS > 60 during active 45 degrees knee flexion will be asked to participate.
Included patients will receive 2xACB (singleshot) first placebo (30ml saline) and then ropivacaine (30ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.
- Conditions
- Pain After Total Knee Arthroplasty
- Being tested
- Ropivacaine, Saline
- Keywords
- Total knee arthroplasty, Adductor canal blockade (ACB), High pain responders, US-guided nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
Arm RP is receiving 30 ml of ropivacaine 7,5 mg/ml at first blockade (ACB) and after 45 minutes another blockade (ACB) with placebo (saline 30 ml).
Arm PR is receiving 30 ml of placebo (saline) at first blockade (ACB) and after 45 minutes another blockade (ACB)with ropivacaine.
SalineDrug
Also called NaCl, placebo
please see intervention description for ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Arm RP | Other | first blockade: ropivacaine 7,5mg/ml 30 ml second blockade: placebo: saline 30 ml Receives: Drug: Ropivacaine; Drug: Saline |
| Arm PR | Other | first blockade: placebo: saline 30 ml second blockade: ropivacaine 7,5mg/ml 30 ml Receives: Drug: Ropivacaine; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in VAS between ACB and placebo during active 45 degrees knee flexion
Measured: 45 minutes
Secondary outcomes (2)
Difference in mean VAS between the groups during active knee flexion
Measured: 15, 30, 60, 75 and 90 minutes
Difference in mean VAS between the groups at rest
Measured: 15, 30, 60, 75 and 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012
- Study completionDec 2012
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 Pain After Total Knee 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrik Grevstad, University Hospital, Gentofte, Copenhagen
- Investigators
- Ulrik Grevstad, MD, Principal investigator, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01549704
- Sponsor's protocol ID
- SM1-UG-11
- Status last verified
- Jan 2013
- First submitted
- 1 Mar 2012
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Grevstad U, Mathiesen O, Lind T, Dahl JB. Effect of adductor canal block on pain in patients with severe pain after total knee arthroplasty: a randomized study with individual patient analysis. Br J Anaesth. 2014 May;112(5):912-9. doi: 10.1093/bja/aet441. Epub 2014 Jan 8.
PubMed 24401802
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adductor-Canal-Blockade on High Pain Responders the 1. or 2. Postoperative Day After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT01549704
- Acronym / sponsor ID
- SM1-UG-11
- Conditions
- Pain After Total Knee Arthroplasty
- Keywords
- Total knee arthroplasty, Adductor canal blockade (ACB), High pain responders, US-guided nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Mar 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.
The purpose of this study is to determine whether Adductor-Canal-Blockade (ACB) is superior to placebo when it comes to analgetic efficacy in high pain responders after Total Knee Arthroplasty (TKA). High pain responders are defined as patients reporting VAS > 60 during knee flexion the 1. or 2. day after surgery.
Detailed description
The patients will be included the 1. or 2. day after surgery. All TKA patients will be screened. Those reporting VAS > 60 during active 45 degrees knee flexion will be asked to participate.
Included patients will receive 2xACB (singleshot) first placebo (30ml saline) and then ropivacaine (30ml ropivacaine 7,5mg/ml) or the other way around (randomized). There will be 45 minutes between the two blockades. The blockades will be ultrasound guided.
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 |
|---|---|---|
| Arm RP | Other | Drug: Ropivacaine, Drug: Salinefirst blockade: ropivacaine 7,5mg/ml 30 ml second blockade: placebo: saline 30 ml |
| Arm PR | Other | Drug: Ropivacaine, Drug: Salinefirst blockade: placebo: saline 30 ml second blockade: ropivacaine 7,5mg/ml 30 ml |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- TKA within 48 hours and VAS>60 during active 45 degrees knee flexion despite conventional pain medication.
- Informed consent
- ASA 1-3
- BMI 18-40
Key exclusion criteria (4 listed)
- Unable to communicate in Danish
- Allergic reactions toward drugs used in the
- Abuse of alcohol/drugs
- Unable to cooperate
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 |
|---|---|---|
| RopivacaineAlso: NaropinArm RP is receiving 30 ml of ropivacaine 7,5 mg/ml at first blockade (ACB) and after 45 minutes another blockade (ACB) with placebo (saline 30 ml). Arm PR is receiving 30 ml of placebo (saline) at first blockade (ACB) and after 45 minutes another blockade (ACB)with ropivacaine. | Drug | Arm PR, Arm RP |
| SalineAlso: NaCl, placeboplease see intervention description for ropivacaine | Drug | Arm PR, Arm RP |
Primary outcome
Difference in VAS between ACB and placebo during active 45 degrees knee flexion
Time frame: 45 minutes
2 secondary outcomes
Difference in mean VAS between the groups during active knee flexion
Time frame: 15, 30, 60, 75 and 90 minutes
Difference in mean VAS between the groups at rest
Time frame: 15, 30, 60, 75 and 90 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 8 Jan 2013.
- Derived from this study: PubMed 24401802Grevstad U, Mathiesen O, Lind T, Dahl JB. Effect of adductor canal block on pain in patients with severe pain after total knee arthroplasty: a randomized study with individual patient analysis. Br J Anaesth. 2014 May;112(5):912-9. doi: 10.1093/bja/aet441. Epub 2014 Jan 8.
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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 and Saline in people with Pain After Total Knee Arthroplasty, run by University Hospital, Gentofte, Copenhagen 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 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 8 Jan 2013. 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?
Difference in VAS between ACB and placebo during active 45 degrees knee flexion (time frame: 45 minutes). 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 NCT01549704, 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 8 Jan 2013.