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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
Participant will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Popliteal Plexus Block with 20 mL of bupivacaine | Experimental |
| |
| Popliteal Plexus Block with 10 mL of bupivacaine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Applied perineurally using a 22-gauge, 80-mm block needle (Temena, Felsberg, Germany) under ultrasound guidance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From T0 (end-of-surgery time) to T24 (24 hours after end-of-surgery time) |
| Measure | Description | Time Frame |
|---|---|---|
| No opioid requirement | The frequency of patients with no opioid consumption | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johan K Sørensen, MD | Elective Surgery Centre at Silkeborg Regional Hospital, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elective Surgery Centre at Silkeborg Regional Hospital | Silkeborg | Denmark Central Region | 8600 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40346895 | Derived | 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. |
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Data is available upon reasonable request.
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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).
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Good-Clinical-Practice monitor is also blinded.
| 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) | 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 | 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. | Assessed at T6 (6±1 end-of-surgery time) |
| Quality of Recovery 15 | Patient reported outcome measure of the Quality of Recovery 15 survey. | Assessed at T24 (24 hours after end-of-surgery time) |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 25, 2026 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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