The Sacral Erector Spinae Plane Block in Total Knee Arthroplasty

NCT07017400 | Recruiting

• 1 other identifier: 143/2025
• Study Type: observational
• Target: 126
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Total Knee Anthroplasty; Regional Anesthesia

Keywords

regional anesthesia; total knee arthroplasty

Outcome Measures

Primary Outcomes (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

  at 24 hours post-surgery

Secondary Outcomes (4)

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

  0-48 hours from surgery

• Time to first mobilization

  0-48 hours

• Analgesic consumption (total drug dosage)

  0-48 hours

• Time to first analgesic request (time - hour - of first request)

  0-48 hours

Study Arms (2)

ACB/iPACK

combination of adductor canal block (saphenous) and infiltration between the Popliteal Artery and Capsule of the Knee (iPACK) block

Procedure: Local Anesthetic Injection

ACB/sacral ESP

combination of adductor canal block (saphenous) and sacral erector spinae plane (ESP) block

Procedure: Local Anesthetic Injection

Interventions

Local Anesthetic Injection PROCEDURE

combination of regional blocks for TKA postoperative analgesia

ACB/iPACK; ACB/sacral ESP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults \>18 years scheduled for unilateral TKA

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Giovanni di Dio Hospital: lead

Study Sites (1)

San Giovanni Crotone Hospital

Crotone, Italy

RECRUITING

Related Publications (7)

• 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.

  PMID: 39600436 BACKGROUND

• 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.

  PMID: 38421355 BACKGROUND

• 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.

  PMID: 38656087 BACKGROUND

• 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.

  PMID: 38187935 BACKGROUND

• 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.

  PMID: 39495168 BACKGROUND

• 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.

  PMID: 30999197 BACKGROUND

• 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.

  PMID: 35852550 BACKGROUND

MeSH Terms

Interventions

Anesthetics, Local

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

Tommaso Sorrentino, Anesthesiology

CONTACT

+393277038017; tommaso.sorrentino@asp.crotone.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 12, 2025
• Study Start: July 16, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

IT (1)