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Total Knee Anthroplastysacral ESPNCT07017400

The Sacral Erector Spinae Plane Block in Total Knee Arthroplasty

An observational study of Total Knee Anthroplasty and Regional Anesthesia, run by San Giovanni di Dio Hospital at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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: ACB + sacral ESP block ACB + iPACK… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Total Knee Anthroplasty, Regional Anesthesia
What is being tested?
Local Anesthetic Injection
How many people
126 participants
Where
1 siteItaly
Study dates
16 Jul 2025to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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

Study population: Adults >18 years scheduled for unilateral TKA

Who may be able to join

  • Adults >18 years
  • ASA I-III
  • scheduled for unilateral TKA with expected hospitalization > 24 hours

Who cannot join

  • Refusal of consent
  • Local anesthetics allergies
  • contraindications to spinal or regional anesthesia
  • coagulation disorders
  • anticoagulation/antiaggregation medications
  • dementia
Show all 9Show fewer
  • ASA-PS > III
  • ongoing infection
  • emergency surgeries

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tommaso Sorrentino, Anesthesiology contact

+393277038017

tommaso.sorrentino@asp.crotone.it

Italy1 site, 1 recruiting

  • San Giovanni Crotone Hospital

    Crotone

    Tommaso Sorrentino, M.D.

    Recruiting

Other trials in Italy

About this study

Official title: Effectiveness of the Sacral Erector Spinae Plane (ESP) Block in Total Knee Arthroplasty: A Prospective Observational Study

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:

  • ACB + sacral ESP block
  • ACB + iPACK block

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.

Read the detailed description

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:

  • Type: Single-center, prospective, observational study
  • Setting: Ospedale di Crotone, Italy
  • Duration: Maximum of 30 months
  • Sample size: 63 patients per group (based on QoR-15 score, with 80% power and α = 0.05)

Population:

  • Adults >18 years (ASA I-III), scheduled for unilateral TKA with expected hospitalization >24 hours
  • Exclusion: refusal of consent, contraindications to spinal or regional anesthesia, coagulation disorders, severe dementia, ongoing infection, or emergency surgeries

Primary Endpoint:

  • Quality of Recovery (QoR-15) score at 24 hours post-surgery (score range 0-150; higher scores indicate better recovery)

Secondary Endpoints:

  • Postoperative pain scores (NRS, score range 0-10, higher scores indicate more pain) at rest and movement (0-48 hours)
  • Time to first mobilization
  • Patient satisfaction (Likert scale)
  • Analgesic consumption and time to first request
  • Incidence of nausea, vomiting, antiemetic use
  • Block-related complications or adverse events

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.

Being tested
Local Anesthetic Injection
Keywords
regional anesthesia, total knee arthroplasty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Local Anesthetic InjectionProcedure or surgery

    combination of regional blocks for TKA postoperative analgesia

Study groups in NCT07017400
Study groupRoleWhat they receive
ACB/iPACKcombination of adductor canal block (saphenous) and infiltration between the Popliteal Artery and Capsule of the Knee (iPACK) block
Receives: Procedure: Local Anesthetic Injection
ACB/sacral ESPcombination of adductor canal block (saphenous) and sacral erector spinae plane (ESP) block
Receives: Procedure: Local Anesthetic Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: at 24 hours post-surgery

Secondary outcomes (4)

  1. 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)

    Measured: 0-48 hours from surgery

  2. Time to first mobilization

    first patient mobilization - time (hour) of first mobilization

    Measured: 0-48 hours

  3. Analgesic consumption (total drug dosage)

    Effectiveness of the blocks

    Measured: 0-48 hours

  4. Time to first analgesic request (time - hour - of first request)

    Duration of the blocks

    Measured: 0-48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2025
  2. Study start16 Jul 2025
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07017400
Sponsor's protocol ID
143/2025
Acronym
sacral ESP
Status last verified
Aug 2025
First submitted
24 May 2025
Last updated
28 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39600436

  • 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.

    PubMed 38421355

  • 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.

    PubMed 38656087

  • 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.

    PubMed 38187935

  • 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.

    PubMed 39495168

  • 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.

    PubMed 30999197

  • 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.

    PubMed 35852550

Questions about this trial

What is this clinical trial studying?

An observational study of Total Knee Anthroplasty and Regional Anesthesia, run by San Giovanni di Dio Hospital at 1 site in Italy.

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 9 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: looking for participants now, as of the sponsor's last update on 28 Aug 2025. 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 Italy. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tommaso Sorrentino, Anesthesiology (+393277038017, tommaso.sorrentino@asp.crotone.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quality of Recovery (QoR-15) score at 24 hours post-surgery (time frame: at 24 hours post-surgery). 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 NCT07017400, which also lists 7 linked publications.

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 28 Aug 2025.

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