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The goal of this observational study is to learn about the analgesic efficacy and postoperative recovery of two locoregional anesthesia combinations in patients > 18 years (ASA I-III), scheduled for unilateral TKA under spinal anesthesia with expected hospitalization > 24 hours:
The main question it aims to answer is: Does the ACB + sacral ESP block combination produce effective postoperative recovery and analgesic effect?
Participants already taking ACB + sacral ESP block as part of their regular peri-operative care for TKA will be followed in the postoperative period for 48 hours.
Total Knee Arthroplasty (TKA) is a common orthopedic surgery in elderly patients, often requiring effective postoperative pain control to enhance recovery. Conventional locoregional techniques include adductor canal block (ACB) and the iPACK block (infiltration between the Popliteal Artery and Capsule of the Knee). While effective, iPACK may carry infection risks due to its proximity to the surgical field.
The sacral ESP block is a more recent ultrasound-guided technique targeting posterior sacral nerve branches from a remote site, potentially avoiding motor weakness and surgical site complications. Early literature and local clinical experience suggest that combining sacral ESP with ACB may provide comparable analgesia to ACB+iPACK while offering practical and safety advantages.
Study Design:
Population:
Primary Endpoint:
Secondary Endpoints:
Procedure:
All patients receive spinal anesthesia and multimodal postoperative analgesia (paracetamol, rescue tramadol). Regional blocks are performed under ultrasound guidance in aseptic conditions. ESP is performed at the S2 level with 20 mL ropivacaine 0.375%. ACB and iPACK are also administered per standard protocols.
Data Analysis:
Statistical comparisons between groups will be made using appropriate parametric or non-parametric tests based on variable distribution. Repeated measures will be analyzed using linear mixed-effects models.
Ethics:
The study follows Good Clinical Practice (GCP) and the Declaration of Helsinki. Patients provide written informed consent. Privacy and data confidentiality are ensured.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACB/iPACK | combination of adductor canal block (saphenous) and infiltration between the Popliteal Artery and Capsule of the Knee (iPACK) block |
| |
| ACB/sacral ESP | combination of adductor canal block (saphenous) and sacral erector spinae plane (ESP) block |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Local Anesthetic Injection | Procedure | combination of regional blocks for TKA postoperative analgesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery (QoR-15) score at 24 hours post-surgery | Quality of Recovery (QoR-15) - score range 0-150 - higher scores indicate better recovery | at 24 hours post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain scores (NRS) at rest and movement (0-48 hours) | NRS at rest and movement - score range 0 (no pain) - 10 (the worst pain) | 0-48 hours from surgery |
| Time to first mobilization |
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Inclusion Criteria:
Exclusion Criteria:
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Adults >18 years scheduled for unilateral TKA
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tommaso Sorrentino, Anesthesiology | Contact | +393277038017 | tommaso.sorrentino@asp.crotone.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Giovanni Crotone Hospital | Recruiting | Crotone | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39600436 | Result | Marrone F, Fusco P, Paventi S, Pullano C. Combined adductor canal (ACB) and sacral erector spinae plane (S-ESP) blocks for total knee arthroplasty pain in hemophilic arthropathy. Saudi J Anaesth. 2024 Oct-Dec;18(4):565-568. doi: 10.4103/sja.sja_177_24. Epub 2024 Oct 2. | |
| 38421355 | Result | Marrone F, Pullano C, Paventi S, Tomei M, Fusco P. A unilateral single level sacral erector spinae plane block for total knee arthroplasty pain. Minerva Anestesiol. 2024 Jul-Aug;90(7-8):707-708. doi: 10.23736/S0375-9393.24.18046-7. Epub 2024 Feb 29. No abstract available. |
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| ID | Term |
|---|---|
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
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first patient mobilization - time (hour) of first mobilization
| 0-48 hours |
| Analgesic consumption (total drug dosage) | Effectiveness of the blocks | 0-48 hours |
| Time to first analgesic request (time - hour - of first request) | Duration of the blocks | 0-48 hours |
| 38656087 | Result | Marrone F, Fusco P, Paventi S, Tomei M, Lolli S, Chironna E, Pullano C. Combined lumbar and sacral erector spinae plane (LS-ESP) block for hip fracture pain and surgery. Minerva Anestesiol. 2024 Jul-Aug;90(7-8):712-714. doi: 10.23736/S0375-9393.24.18093-5. Epub 2024 Apr 24. No abstract available. |
| 38187935 | Result | Marrone F, Paventi S, Tomei M, Failli S, Crecco S, Pullano C. Unilateral sacral erector spinae plane block for hip fracture surgery. Anaesth Rep. 2024 Jan 3;12(1):e12269. doi: 10.1002/anr3.12269. eCollection 2024 Jan-Jun. |
| 39495168 | Result | Satici MH, Tutar MS, Tire Y, Binici O, Cicekler O, Korkmaz E, Pekince O, Kozanhan B. The effect of sacral erector spinae plane block on the quality of recovery after total hip arthroplasty: a prospective, randomized, controlled, multicenter study. Minerva Anestesiol. 2025 Apr;91(4):278-285. doi: 10.23736/S0375-9393.24.18353-8. Epub 2024 Nov 4. |
| 30999197 | Result | Tulgar S, Senturk O, Thomas DT, Deveci U, Ozer Z. A new technique for sensory blockage of posterior branches of sacral nerves: Ultrasound guided sacral erector spinae plane block. J Clin Anesth. 2019 Nov;57:129-130. doi: 10.1016/j.jclinane.2019.04.014. Epub 2019 Apr 15. No abstract available. |
| 35852550 | Result | Lavand'homme PM, Kehlet H, Rawal N, Joshi GP; PROSPECT Working Group of the European Society of Regional Anaesthesia and Pain Therapy (ESRA). Pain management after total knee arthroplasty: PROcedure SPEcific Postoperative Pain ManagemenT recommendations. Eur J Anaesthesiol. 2022 Sep 1;39(9):743-757. doi: 10.1097/EJA.0000000000001691. Epub 2022 Jul 20. |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |