Pain, AcutePhase 4NCT04854395
Femoral Triangle Block With Popliteal Plexus Block Versus Femoral Triangle Block Versus Adductor Canal Block for TKA
A Phase 4 study testing Marcain 5 mg/ml in people with Pain, Acute and Opioid Use, run by Regionshospitalet Silkeborg at 1 site in Denmark.
Trial summary
In this study we wish to investigate the analgesic effect 3 different nerve block regimes in patients following primary total knee arthroplasty (TKA). All nerve blocks were performed as single shot blocks with the administration of Marcain 5 mg/ml. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Pain, Acute, Opioid Use, Analgesia
- What is being tested?
- Marcain 5 mg/ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Apr 2021to 26 Jun 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo primary total knee arthroplasty in spinal anesthesia
- Able to perform a Timed Up and Go (TUG) test
- Age > 50 years old
- Ability to give their written informed consent to participating in the study after having fully understood the contents of the study
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
Who cannot join
- Patients who cannot cooperate
- Patients who cannot understand or speak Danish.
- Patients with allergy or intolerance to the medicines used in the study
- Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl)
- Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment
- BMI > 40
- Diagnosed with chronic central or peripheral neurodegenerative disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Popliteal Plexus Block on Postoperative Opioid Consumption, Pain, Muscle Strength and Mobilization After Total Knee Arthroplasty - a Randomized, Controlled, Blinded Study
In this study we wish to investigate the analgesic effect 3 different nerve block regimes in patients following primary total knee arthroplasty (TKA). All nerve blocks were performed as single shot blocks with the administration of Marcain 5 mg/ml.
Regime A: proximal Femoral Triangle Block (FTB) with 10 ml including Intermediate Femoral Cutaneous Nerve Block (IFCNB) with 5 ml + Popliteal Plexus Block (PPB) with 10 ml.
Regime B: proximal FTB with 10 ml including IFCNB with 5 ml.
Regime C: Adductor Canal Block (ACB) with 25 ml.
Read the detailed description
The Adductor Canal Block (ACB) is frequently used after TKA, but it is limited to provide anesthesia from the anteromedial part of the knee region. The proximal Femoral Triangle Block (FTB) is also used for TKA, and also limited to provide anesthesia from the anterior medial part of the knee joint. The FTB anesthetize the saphenus nerve, the nerve to vastus medialis, and may anesthetize the medial femoral cutaneous nerve which innervates the distal medial thigh as well as the anteromedial knee region. We included the Intermediate Femoral Cutaneous Nerve block (IFCNB) in the FTB, as the nerves can be targeted in the subcutis on the anterior thigh and easily be anesthetized during the same procedure as FTB. IFCNB anesthetize the distal anterior thigh, which may include the proximal part of the surgical incision for TKA. In the following text the proximal FTB including IFCNB will be refered as "FTB" and the dose of 15 ml will refer to 10 ml for the proximal FTB and 5 ml used for the IFCNB.
A new nerve block technique, called Popliteal Plexus Block (PPB), is specifically designed to anaesthetize nerves involved in innervation of the back of the knee joint. The analgesic effect of PPB has not yet been evaluated in randomized, controlled, blinded trials. In order to optimize pain treatment for primary TKA by improving the pain-relieving effect of peripheral nerve blocks, we aim to evaluate the analgesic effects of three different nerve block regimens (FTB + PPB versus FTB versus ACB) after primary unilateral TKA. Our outcomes include postoperative pain scores, opioid consumption, muscle strength and mobilization.
Our hypothesis is that the combination of FTB + PPB provides superior postoperative pain treatment after TKA in comparison to both FTB or ACB. The combination of FTB + PPB will reduce opioid consumption (primary outcome) and postoperative pain scores without reducing muscle strength or impairing mobilization.
- Conditions
- Pain, Acute, Opioid Use, Analgesia
- Being tested
- Marcain 5 mg/ml
- Medical subject headings
- Acute Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marcain 5 mg/mlDrug
Total volumes of Marcain differs in each arm, depending on which nerve blocks the patients is randomized to receive. Sham block does not include injection of placebo saline, due to the risk of hydrodissection between the anatomical sections which may erase the isolation of the different nerve blocks. Instead the sham block include imitation of the real nerve block, including correct placement of the needle on the target for the block.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Active FTB + Active PPB + Sham ACB | Active comparator | Single shot bolus of 10 ml Marcain 5 mg/ml is used for FTB, 5 ml Marcain 5 mg/ml for IFCN + 10 ml Marcain 5 mg/ml is used for PPB Receives: Drug: Marcain 5 mg/ml |
| Group B: Active FTB + Sham PPB + Sham ACB | Active comparator | Single shot bolus of 10 ml Marcain 5 mg/ml is used for FTB, 5 ml Marcain 5 mg/ml is used for IFCN Receives: Drug: Marcain 5 mg/ml |
| Group C: Sham FTB + Sham PPB + Active ACB | Active comparator | Single shot bolus of 25 ml Marcain 5 mg/ml is used for ACB Receives: Drug: Marcain 5 mg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption in each group, A, B and C
Total opioid consumption is the aggregate of the opioid administered by the Patient Controlled Analgesia (PCA) pump and any potential rescue opioids administered, calculated as IV morphine equivalents
Measured: from time of skin closure (end of surgery) until 24 hours postoperative
Secondary outcomes (11)
Total opioid consumption in each group, A, B and C
Total opioid consumption is the aggregate of the opioid administered by the PCA pump and any potential rescue opioids administered, calculated as IV morphine equivalents
Measured: from time of skin closure (end of surgery) until 12 hours postoperative
Post-block Maximum Voluntary Isometric Contraction (MVIC) by knee extension, calculated as a percentage of the Pre-block baseline value
Both MVIC test are assessed preoperative, using a handheld dynamometer
Measured: A 60 minutes interval is between pre-block and post-block MVIC assessments
Post-block MVIC by ankle plantarflexion, calculated as a percentage of the Pre-block baseline value
Both MVIC test are assessed preoperative, using a handheld dynamometer
Measured: A 60 minutes interval is between pre-block and post-block MVIC assessments
Post-block MVIC by ankle dorsiflexion, calculated as a percentage of the Pre-block baseline value
Both MVIC test are assessed preoperative, using a handheld dynamometer
Measured: A 60 minutes interval is between pre-block and post-block MVIC assessments
Muscle strength of knee extension, graded by Manual Muscle Test (MMT)
Grade 3: Able to extend the knee in active Range of Motion (ROM) against gravity, Grade 2: Patient is lying on the side, with knee resting on the bed, able to extend the knee in active ROM with minimal assistance from the investigator, Grade 1: Muscle contraction of the quadriceps muscle is palpable or observable but the knee does not extend, Grade 0: No muscle contraction of the quadriceps muscle is palpable or observable
Measured: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours after time of skin closure (end of surgery)
Muscle strength of ankle plantarflexion, graded by MMT
Grade 3: Able to plantarflex in active ROM, Grade 2: Patient is lying on the side, with ankle resting on the bed, able to plantarflex the ankle in active ROM with minimal assistance from the investigator, Grade 1: Muscle contraction of the gastrocnemius muscle is palpable or observable but the ankle does not plantarflex, Grade 0: No muscle contraction of the gastrocnemius muscle is palpable or observable
Measured: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours after time of skin closure (end of surgery)
Muscle strength of ankle dorsiflexion, graded by MMT
Grade 3: Able to dorsiflex in active ROM Grade 2: Patient is lying on the side, with ankle resting on the bed, able to dorsiflex the ankle in active ROM with minimal assistance from the investigator, Grade 1: Muscle contraction of the tibialis anterior muscle is palpable or observable but the ankle does not dorsiflex, Grade 0: No muscle contraction of the tibialis anterior muscle is palpable or observable
Measured: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours after time of skin closure (end of surgery)
Timed Up and Go (TUG) test postoperative
Measure of seconds it takes a patient to get up from a chair with armrest, walk a distance of three meters, turn around, walk back and sit down again. All patients must use crutches for the test. If patient cannot mobilize with crutches, the test will not be performed.
Measured: Assessed 5 hours after time of skin closure (end of surgery)
Worst pain during TUG
Patient will be asked to indicate worst pain, Numeric Rating Scale (NRS), 0-10, experienced during the TUG test
Measured: Assessed at the end og the TUG test, 5 hours after time of skin closure (end of surgery)
Pain at rest
Patient will be asked to indicate pain intensity at rest (NRS, 0-10)
Measured: preoperative (preblock baseline), 2, 5 (prior to TUG test), 7, 20 and 24 hours after time of skin closure (end of surgery)
Pain during 90 degrees active flexion of the knee
Patient will be asked to indicate worst pain intensity during active flexion of the knee towards 90 degrees (NRS, 0-10)
Measured: preoperative (preblock baseline), 2, 5 (prior to TUG test), 7, 20 and 24 hours after time of skin closure (end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start9 Apr 2021
- Primary completion26 Jun 2023
- Study completion26 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies 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
- Model description
- Patients assigned for total knee arthroplasty are randomized into one of the three study groups in accordance to a computer-generated block randomization list in a 1:1:1 ratio (each block containing 15 numbers). Prior to surgery the patients receive the peripheral nerve blocks allocated to the group/arm they belong to: Group A: FTB (active) + ACB (sham) + PPB (active) Group B: FTB (active) + ACB (sham) + PPB (sham) Group C: FTB (sham) + ACB (active) + PPB (sham)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regionshospitalet Silkeborg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan Kløvgaard Sørensen, Regionshospitalet Silkeborg
- Investigators
- Charlotte Runge, PhD, Principal investigator, Region Hospital Silkeborg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04854395
- Sponsor's protocol ID
- Protocol_PPB_TKA_16032021
- Other IDs
- 2021-000242-17
- Status last verified
- Nov 2023
- First submitted
- 18 Apr 2021
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared after acceptance from the The Danish Data Protection Agency
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Popliteal Plexus Block on Postoperative Opioid Consumption, Pain, Muscle Strength and Mobilization After Total Knee Arthroplasty - a Randomized, Controlled, Blinded Study
- ClinicalTrials.gov ID
- NCT04854395
- Acronym / sponsor ID
- Protocol_PPB_TKA_16032021
- Conditions
- Pain, Acute, Opioid Use, Analgesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Regionshospitalet SilkeborgUniversity, hospital or other
- Study start
- 9 Apr 2021 (actual)
- Primary completion
- 26 Jun 2023 (actual)
- Study completion
- 26 Jun 2023 (actual)
- First posted
- 22 Apr 2021 (actual)
- 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.
In this study we wish to investigate the analgesic effect 3 different nerve block regimes in patients following primary total knee arthroplasty (TKA). All nerve blocks were performed as single shot blocks with the administration of Marcain 5 mg/ml.
Regime A: proximal Femoral Triangle Block (FTB) with 10 ml including Intermediate Femoral Cutaneous Nerve Block (IFCNB) with 5 ml + Popliteal Plexus Block (PPB) with 10 ml.
Regime B: proximal FTB with 10 ml including IFCNB with 5 ml.
Regime C: Adductor Canal Block (ACB) with 25 ml.
Detailed description
The Adductor Canal Block (ACB) is frequently used after TKA, but it is limited to provide anesthesia from the anteromedial part of the knee region. The proximal Femoral Triangle Block (FTB) is also used for TKA, and also limited to provide anesthesia from the anterior medial part of the knee joint. The FTB anesthetize the saphenus nerve, the nerve to vastus medialis, and may anesthetize the medial femoral cutaneous nerve which innervates the distal medial thigh as well as the anteromedial knee region. We included the Intermediate Femoral Cutaneous Nerve block (IFCNB) in the FTB, as the nerves can be targeted in the subcutis on the anterior thigh and easily be anesthetized during the same procedure as FTB. IFCNB anesthetize the distal anterior thigh, which may include the proximal part of the surgical incision for TKA. In the following text the proximal FTB including IFCNB will be refered as "FTB" and the dose of 15 ml will refer to 10 ml for the proximal FTB and 5 ml used for the IFCNB.
A new nerve block technique, called Popliteal Plexus Block (PPB), is specifically designed to anaesthetize nerves involved in innervation of the back of the knee joint. The analgesic effect of PPB has not yet been evaluated in randomized, controlled, blinded trials. In order to optimize pain treatment for primary TKA by improving the pain-relieving effect of peripheral nerve blocks, we aim to evaluate the analgesic effects of three different nerve block regimens (FTB + PPB versus FTB versus ACB) after primary unilateral TKA. Our outcomes include postoperative pain scores, opioid consumption, muscle strength and mobilization.
Our hypothesis is that the combination of FTB + PPB provides superior postoperative pain treatment after TKA in comparison to both FTB or ACB. The combination of FTB + PPB will reduce opioid consumption (primary outcome) and postoperative pain scores without reducing muscle strength or impairing mobilization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Patients assigned for total knee arthroplasty are randomized into one of the three study groups in accordance to a computer-generated block randomization list in a 1:1:1 ratio (each block containing 15 numbers). Prior to surgery the patients receive the peripheral nerve blocks allocated to the group/arm they belong to: Group A: FTB (active) + ACB (sham) + PPB (active) Group B: FTB (active) + ACB (sham) + PPB (sham) Group C: FTB (sham) + ACB (active) + PPB (sham)
| Arm | Type | Receives |
|---|---|---|
| Group A: Active FTB + Active PPB + Sham ACB | Active comparator | Drug: Marcain 5 mg/mlSingle shot bolus of 10 ml Marcain 5 mg/ml is used for FTB, 5 ml Marcain 5 mg/ml for IFCN + 10 ml Marcain 5 mg/ml is used for PPB |
| Group B: Active FTB + Sham PPB + Sham ACB | Active comparator | Drug: Marcain 5 mg/mlSingle shot bolus of 10 ml Marcain 5 mg/ml is used for FTB, 5 ml Marcain 5 mg/ml is used for IFCN |
| Group C: Sham FTB + Sham PPB + Active ACB | Active comparator | Drug: Marcain 5 mg/mlSingle shot bolus of 25 ml Marcain 5 mg/ml is used for ACB |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Scheduled to undergo primary total knee arthroplasty in spinal anesthesia
- Able to perform a Timed Up and Go (TUG) test
- Age > 50 years old
- Ability to give their written informed consent to participating in the study after having fully understood the contents of the study
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
Key exclusion criteria (7 listed)
- Patients who cannot cooperate
- Patients who cannot understand or speak Danish.
- Patients with allergy or intolerance to the medicines used in the study
- Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl)
- Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment
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 |
|---|---|---|
| Marcain 5 mg/mlTotal volumes of Marcain differs in each arm, depending on which nerve blocks the patients is randomized to receive. Sham block does not include injection of placebo saline, due to the risk of hydrodissection between the anatomical sections which may erase the isolation of the different nerve blocks. Instead the sham block include imitation of the real nerve block, including correct placement of the needle on the target for the block. | Drug | Group A: Active FTB + Active PPB + Sham ACB, Group B: Active FTB + Sham PPB + Sham ACB, Group C: Sham FTB + Sham PPB + Active ACB |
Primary outcome
Total opioid consumption in each group, A, B and C
Time frame: from time of skin closure (end of surgery) until 24 hours postoperative
Total opioid consumption is the aggregate of the opioid administered by the Patient Controlled Analgesia (PCA) pump and any potential rescue opioids administered, calculated as IV morphine equivalents
11 secondary outcomes
Total opioid consumption in each group, A, B and C
Time frame: from time of skin closure (end of surgery) until 12 hours postoperative
Post-block Maximum Voluntary Isometric Contraction (MVIC) by knee extension, calculated as a percentage of the Pre-block baseline value
Time frame: A 60 minutes interval is between pre-block and post-block MVIC assessments
Post-block MVIC by ankle plantarflexion, calculated as a percentage of the Pre-block baseline value
Time frame: A 60 minutes interval is between pre-block and post-block MVIC assessments
Post-block MVIC by ankle dorsiflexion, calculated as a percentage of the Pre-block baseline value
Time frame: A 60 minutes interval is between pre-block and post-block MVIC assessments
Muscle strength of knee extension, graded by Manual Muscle Test (MMT)
Time frame: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours after time of skin closure (end of surgery)
Muscle strength of ankle plantarflexion, graded by MMT
Time frame: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours after time of skin closure (end of surgery)
Muscle strength of ankle dorsiflexion, graded by MMT
Time frame: Assessed pre-block, post-block (60 minutes after pre-block) and postoperative 5 hours after time of skin closure (end of surgery)
Timed Up and Go (TUG) test postoperative
Time frame: Assessed 5 hours after time of skin closure (end of surgery)
Worst pain during TUG
Time frame: Assessed at the end og the TUG test, 5 hours after time of skin closure (end of surgery)
Pain at rest
Time frame: preoperative (preblock baseline), 2, 5 (prior to TUG test), 7, 20 and 24 hours after time of skin closure (end of surgery)
Pain during 90 degrees active flexion of the knee
Time frame: preoperative (preblock baseline), 2, 5 (prior to TUG test), 7, 20 and 24 hours after time of skin closure (end of surgery)
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 18 Nov 2023.
- Individual participant dataSharing planned: Yes. Data will be shared after acceptance from the The Danish Data Protection Agency
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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.
Charlotte Runge, PhD principal investigator
Region Hospital Silkeborg
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 Marcain 5 mg/ml in people with Pain, Acute and Opioid Use, run by Regionshospitalet Silkeborg 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 5 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 18 Nov 2023. 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?
Total opioid consumption in each group, A, B and C (time frame: from time of skin closure (end of surgery) until 24 hours postoperative). 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 18 Nov 2023.