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NCT Number: NCT07017400

The Sacral Erector Spinae Plane Block in Total Knee Arthroplasty

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

San Giovanni Crotone Hospital

Crotone, Italy

Location status: Recruiting

Location contact

Tommaso Sorrentino, M.D.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Local Anesthetic Injection

Procedure

combination of regional blocks for TKA postoperative analgesia

Primary outcomes

  1. Quality of Recovery (QoR-15) score at 24 hours post-surgery

    Time frame: at 24 hours post-surgery

    Quality of Recovery (QoR-15) - score range 0-150 - higher scores indicate better recovery

Secondary outcomes

  1. Postoperative pain scores (NRS) at rest and movement (0-48 hours)

    Time frame: 0-48 hours from surgery

    NRS at rest and movement - score range 0 (no pain) - 10 (the worst pain)

  2. Time to first mobilization

    Time frame: 0-48 hours

    first patient mobilization - time (hour) of first mobilization

  3. Analgesic consumption (total drug dosage)

    Time frame: 0-48 hours

    Effectiveness of the blocks

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

    Time frame: 0-48 hours

    Duration of the blocks

Study contacts

Contact information is provided by the study sponsor or research team.

Tommaso Sorrentino, Anesthesiology

CONTACT

[email protected]

+393277038017

Sponsors and collaborators

Lead sponsor

San Giovanni di Dio Hospital

Other

Registry information

Official study title

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

Acronym: sacral ESP

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 12, 2025
Registry last updated
Aug 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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