Total Knee ArthroplastyPhase 4NCT06908837
Effects of 10 Versus 20 mL Local Anesthetic for Popliteal Plexus Block on Opioid Consumption, Pain, and Patient-Reported Outcomes After Total Knee Arthroplasty
A Phase 4 study testing Bupivacaine in people with Total Knee Arthroplasty and Regional Anesthesia, run by Regionshospitalet Silkeborg at 1 site in Denmark.
Trial summary
This trial aims to assess the analgesic effect of Popliteal Plexus Block (PPB) with 10 mL versus 20 mL of Bupivacain 5 mg/mL, when applied as an adjunct treatment to a multimodal analgesic regimen following primary total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Regional Anesthesia, Multimodal Analgesic Approach
- What is being tested?
- Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteDenmark
- Study dates
- 7 Apr 2025to 26 Nov 2025
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo primary total knee arthroplasty in spinal anesthesia.
- Ability to give their written informed consent 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 read or speak Danish.
- Patients who cannot operate or have access to a smartphone with internet connectivity (required for patient-reported outcome assessment).
- Patients with allergies or intolerance to the medicines used in the study.
- Patients with a consistent daily intake of opioids preoperatively.
- Patients who are dependent on walking aid devices preoperatively.
- Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment.
- BMI > 40.
- Diagnosed with chronic neurodegenerative disorders.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Elective Surgery Centre at Silkeborg Regional Hospital
Silkeborg, Denmark Central Region, 8600
About this study
Official title: Effects of 10 Versus 20 mL Local Anesthetic for Popliteal Plexus Block on Opioid Consumption, Pain, and Patient-Reported Outcomes After Total Knee Arthroplasty - a Randomized, Controlled, Blinded Study
This trial aims to assess the analgesic effect of Popliteal Plexus Block (PPB) with 10 mL versus 20 mL of Bupivacain 5 mg/mL, when applied as an adjunct treatment to a multimodal analgesic regimen following primary total knee arthroplasty. We hypothesize that PPB with 20 mL of local anesthetic reduces 24-hour postoperative opioid consumption (= primary outcome) compared to 10 mL after TKA.
Secondary outcome include
Read more
- the frequency of 24-hour opioid-free analgesia
- pain intensity at rest and during mobilization
- Manual Muscle Tests and ability to mobilize with crutches six hours after end-of-surgery
- and patients reported outcomes using the Quality of Recovery 15 survey 24 hours after end-of-surgery.
Participant will:
- undergo primary total knee arthroplasty in spinal anesthesia.
- recieve a PPB with either 10 mL of Bupivacaine or 20 mL.
- recieve a multimodal analgesic regime including a Femoral Triangle Block.
- Have 10 scored morphine tablets available for self-administration within the first 24 postoperative hours after end-of-surgery.
- be examined by a physiotherapist 6 hours (±1 hour) after end-of-surgery to assess pain scores, manual muscle testing of ankle and knee function, and the ability to mobilize with crutches.
- complete a survey 24 hours after end-of-surgery to assess self-administered morphine intake, pain scores, and Quality of Recovery-15.
Read the detailed description
Patients will undergo primary unilateral total knee arthroplasty with insertion of non-cruciate retaining standard cemented prosthesis by a parapatellar medial approach, without use of tourniquet or Local Infiltration Analgesia.
For the spinal anesthesia, 3 mL of Ropivacaine 5 mg/ml will be applied.
All patients will receive a femoral triangle block in combination with the PPB, both administered immediately after surgery in the post-anesthesia care unit.
Description of the PPB procedure:
The superficial femoral artery is identified at mid-thigh level and traced caudally until it deviates from sartorius muscle and is positioned adjacent to the posteromedial margin of the vastus medialis muscle, close to the adductor hiatus. The needle will be inserted medially to the transducer and advanced in-plane through the sartorius muscle targeting the endpoint of injection in the distal part of the adductor canal, on the top of the superficial femoral artery, posteromedial to the fascia of the vastus medialis muscle. We will inject the allocated volume of bupivacaine 5 mg/mL, ensuring anterolaterally spread to the artery
The Femoral Triangle Block uses 15 mL of Bupivacaine 5 mg/mL (10 mL applied in the femoral triangle to target the saphenous nerve and nerve to vastus medialis and 5 mL applied to target the intermediate femoral cutaneous nerve located at the superficial side of the sartorius muscle).
The multimodal analgesic regime also consists of a Dexamethasone 12 mg IV (administered perioperatively), Paracetamol (1000 mg) x 4 daily + NSAID (400 mg) x 3 times daily postoperatively, inclusing preoperatively administration of Paracetamol 1000 mg and Ibuprofen 400 mg.
The scored morphine tablets allows the patients to take 5 mg morphine at a time, with a maximum oral dose of 100 mg within the first 24 hours after end-of-surgery time. If needed, hospital staff can administer rescue doses of intravenous morphine, which will be recorded in the patient file. Total opioid consumption will be reported as oral morphine milligram equivalents (MME), combining hospital-administered opioid doses from the patient file and self-reported intake of dispensed morphine tablets.
- Conditions
- Total Knee Arthroplasty, Regional Anesthesia, Multimodal Analgesic Approach, Postoperative Opioid-related Complications
- Being tested
- Bupivacaine
- Keywords
- Popliteal Plexus Block, Total knee arthroplasty, regional anesthesia, optimal analgesic volume, postoperative pain, postoperative opioid consumption, Quality of Recovery 15, Manual Muscle Test, Postoperative mobility
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Applied perineurally using a 22-gauge, 80-mm block needle (Temena, Felsberg, Germany) under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Popliteal Plexus Block with 20 mL of bupivacaine | Experimental | Not described Receives: Drug: Bupivacaine |
| Popliteal Plexus Block with 10 mL of bupivacaine | Active comparator | Not described Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption, expressed in oral morphine milligram equivalents (MME).
Combining hospital-administered opioid doses from the patient file and self-reported intake of dispensed morphine tablets.
Measured: From T0 (end-of-surgery time) to T24 (24 hours after end-of-surgery time)
Secondary outcomes (6)
No opioid requirement
The frequency of patients with no opioid consumption
Measured: From T0 (end-of-surgery time) to T24 (24 hours after end-of-surgery time)
Pain at rest
Registered using the Numeric Rating Scale (0 = no pain and 10 = worst imaginable pain)
Measured: Assessed preoperatively, at T6 (6±1 hours after end-of-surgery time), and at T24 (24 hours after end-of-surgery time).
Pain during 10 meters walk assisted only by crutches
Registered using the Numeric Rating Scale (0 = no pain and 10 = worst imaginable pain)
Measured: Assessed preoperatively, at T6 (6±1 hours after end-of-surgery time), and at T24 (24 hours after end-of-surgery time).
Early postoperative walking ability
The frequency of patients unable to walk 10 meters with crutches at T6
Measured: Assessed at T6 (6±1 end-of-surgery time)
Postoperative Manual Muscle Test
Frequency of patients with Manual Muscle Test results < Grade 3 in evaluations of dorsiflexion and plantarflexion of the ankle and knee extension.
Grade 5: Patient can move the limb in the intended direction against gravity and maximum manual resistance. Grade 4: Patient can move the limb in the intended direction against gravity and moderate manual resistance. Grade 3: Patient can move the limb in the intended direction against gravity without resistance. Grade 2: Patient can move the limb in the intended direction only by elimination of the gravity or with minimal assistance from the investigator. Grade 1: Patient is unable to move the limb in the intended direction, but muscle contraction of the respective muscle is palpable or observable. Grade 0: No muscle contraction of the respective muscle is palpable or observable.
Measured: Assessed at T6 (6±1 end-of-surgery time)
Quality of Recovery 15
Patient reported outcome measure of the Quality of Recovery 15 survey.
Measured: Assessed at T24 (24 hours after end-of-surgery time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start7 Apr 2025
- Primary completion26 Nov 2025
- Study completion26 Nov 2025
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 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
- Model description
- This single-centre, blinded, controlled, randomized clinical trial follows a parallel design, with one group receiving a PPB with 10 mL of bupivacaine 5 mg/mL and the other group receiving a PPB with 20 mL of bupivacaine 5 mg/mL. A total of 120 patients will be included and allocated in a 1:1 ratio using computer-generated block randomization (blocks of 10).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 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
- Johan K Sørensen, MD, Principal investigator, Elective Surgery Centre at Silkeborg Regional Hospital, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06908837
- Sponsor's protocol ID
- 2024-520204-26-00
- Status last verified
- Jan 2026
- First submitted
- 26 Mar 2025
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data is available upon reasonable request.
Publications
Sorensen JK, Jensen MSH, Grevstad U, Nikolajsen L, Runge C. Optimal Analgesic Volume for Popliteal Plexus Block After Total Knee Arthroplasty: A Blinded RCT Protocol. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70057. doi: 10.1111/aas.70057.
PubMed 40346895
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 10 Versus 20 mL Local Anesthetic for Popliteal Plexus Block on Opioid Consumption, Pain, and Patient-Reported Outcomes After Total Knee Arthroplasty - a Randomized, Controlled, Blinded Study
- ClinicalTrials.gov ID
- NCT06908837
- Acronym / sponsor ID
- 2024-520204-26-00
- Conditions
- Total Knee Arthroplasty, Regional Anesthesia, Multimodal Analgesic Approach, Postoperative Opioid-related Complications
- Keywords
- Popliteal Plexus Block, Total knee arthroplasty, regional anesthesia, optimal analgesic volume, postoperative pain, postoperative opioid consumption, Quality of Recovery 15, Manual Muscle Test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Regionshospitalet SilkeborgUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 26 Nov 2025 (actual)
- Study completion
- 26 Nov 2025 (actual)
- First posted
- 3 Apr 2025 (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.
This trial aims to assess the analgesic effect of Popliteal Plexus Block (PPB) with 10 mL versus 20 mL of Bupivacain 5 mg/mL, when applied as an adjunct treatment to a multimodal analgesic regimen following primary total knee arthroplasty. We hypothesize that PPB with 20 mL of local anesthetic reduces 24-hour postoperative opioid consumption (= primary outcome) compared to 10 mL after TKA.
Secondary outcome include
- the frequency of 24-hour opioid-free analgesia
- pain intensity at rest and during mobilization
- Manual Muscle Tests and ability to mobilize with crutches six hours after end-of-surgery
- and patients reported outcomes using the Quality of Recovery 15 survey 24 hours after end-of-surgery.
Participant will:
- undergo primary total knee arthroplasty in spinal anesthesia.
- recieve a PPB with either 10 mL of Bupivacaine or 20 mL.
- recieve a multimodal analgesic regime including a Femoral Triangle Block.
- Have 10 scored morphine tablets available for self-administration within the first 24 postoperative hours after end-of-surgery.
- be examined by a physiotherapist 6 hours (±1 hour) after end-of-surgery to assess pain scores, manual muscle testing of ankle and knee function, and the ability to mobilize with crutches.
- complete a survey 24 hours after end-of-surgery to assess self-administered morphine intake, pain scores, and Quality of Recovery-15.
Detailed description
Patients will undergo primary unilateral total knee arthroplasty with insertion of non-cruciate retaining standard cemented prosthesis by a parapatellar medial approach, without use of tourniquet or Local Infiltration Analgesia.
For the spinal anesthesia, 3 mL of Ropivacaine 5 mg/ml will be applied.
All patients will receive a femoral triangle block in combination with the PPB, both administered immediately after surgery in the post-anesthesia care unit.
Description of the PPB procedure:
The superficial femoral artery is identified at mid-thigh level and traced caudally until it deviates from sartorius muscle and is positioned adjacent to the posteromedial margin of the vastus medialis muscle, close to the adductor hiatus. The needle will be inserted medially to the transducer and advanced in-plane through the sartorius muscle targeting the endpoint of injection in the distal part of the adductor canal, on the top of the superficial femoral artery, posteromedial to the fascia of the vastus medialis muscle. We will inject the allocated volume of bupivacaine 5 mg/mL, ensuring anterolaterally spread to the artery
The Femoral Triangle Block uses 15 mL of Bupivacaine 5 mg/mL (10 mL applied in the femoral triangle to target the saphenous nerve and nerve to vastus medialis and 5 mL applied to target the intermediate femoral cutaneous nerve located at the superficial side of the sartorius muscle).
The multimodal analgesic regime also consists of a Dexamethasone 12 mg IV (administered perioperatively), Paracetamol (1000 mg) x 4 daily + NSAID (400 mg) x 3 times daily postoperatively, inclusing preoperatively administration of Paracetamol 1000 mg and Ibuprofen 400 mg.
The scored morphine tablets allows the patients to take 5 mg morphine at a time, with a maximum oral dose of 100 mg within the first 24 hours after end-of-surgery time. If needed, hospital staff can administer rescue doses of intravenous morphine, which will be recorded in the patient file. Total opioid consumption will be reported as oral morphine milligram equivalents (MME), combining hospital-administered opioid doses from the patient file and self-reported intake of dispensed morphine tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This single-centre, blinded, controlled, randomized clinical trial follows a parallel design, with one group receiving a PPB with 10 mL of bupivacaine 5 mg/mL and the other group receiving a PPB with 20 mL of bupivacaine 5 mg/mL. A total of 120 patients will be included and allocated in a 1:1 ratio using computer-generated block randomization (blocks of 10).
| Arm | Type | Receives |
|---|---|---|
| Popliteal Plexus Block with 20 mL of bupivacaine | Experimental | Drug: Bupivacaine |
| Popliteal Plexus Block with 10 mL of bupivacaine | Active comparator | Drug: Bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to undergo primary total knee arthroplasty in spinal anesthesia.
- Ability to give their written informed consent after having fully understood the contents of the study.
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3.
Key exclusion criteria (8 listed)
- Patients who cannot read or speak Danish.
- Patients who cannot operate or have access to a smartphone with internet connectivity (required for patient-reported outcome assessment).
- Patients with allergies or intolerance to the medicines used in the study.
- Patients with a consistent daily intake of opioids preoperatively.
- Patients who are dependent on walking aid devices preoperatively.
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 |
|---|---|---|
| BupivacaineApplied perineurally using a 22-gauge, 80-mm block needle (Temena, Felsberg, Germany) under ultrasound guidance. | Drug | Popliteal Plexus Block with 10 mL of bupivacaine, Popliteal Plexus Block with 20 mL of bupivacaine |
Primary outcome
Total opioid consumption, expressed in oral morphine milligram equivalents (MME).
Time frame: From T0 (end-of-surgery time) to T24 (24 hours after end-of-surgery time)
Combining hospital-administered opioid doses from the patient file and self-reported intake of dispensed morphine tablets.
6 secondary outcomes
No opioid requirement
Time frame: From T0 (end-of-surgery time) to T24 (24 hours after end-of-surgery time)
Pain at rest
Time frame: Assessed preoperatively, at T6 (6±1 hours after end-of-surgery time), and at T24 (24 hours after end-of-surgery time).
Pain during 10 meters walk assisted only by crutches
Time frame: Assessed preoperatively, at T6 (6±1 hours after end-of-surgery time), and at T24 (24 hours after end-of-surgery time).
Early postoperative walking ability
Time frame: Assessed at T6 (6±1 end-of-surgery time)
Postoperative Manual Muscle Test
Time frame: Assessed at T6 (6±1 end-of-surgery time)
Quality of Recovery 15
Time frame: Assessed at T24 (24 hours after end-of-surgery time)
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 22 Jan 2026.
- Derived from this study: PubMed 40346895Sorensen JK, Jensen MSH, Grevstad U, Nikolajsen L, Runge C. Optimal Analgesic Volume for Popliteal Plexus Block After Total Knee Arthroplasty: A Blinded RCT Protocol. Acta Anaesthesiol Scand. 2025 Jul;69(6):e70057. doi: 10.1111/aas.70057.
- Individual participant dataSharing planned: Undecided. Data is available upon reasonable request.
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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.
Johan K Sørensen, MD principal investigator
Elective Surgery Centre at Silkeborg Regional Hospital, Denmark
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 Bupivacaine in people with Total Knee Arthroplasty and Regional Anesthesia, 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 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 22 Jan 2026. 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, expressed in oral morphine milligram equivalents (MME). (time frame: From T0 (end-of-surgery time) to T24 (24 hours after end-of-surgery time)). 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 NCT06908837, 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 22 Jan 2026.