Sacral ESP plus adductor canal block versus iPACK plus adductor canal block for pain control after knee replacement
Official title: Effectiveness of the Sacral Erector Spinae Plane (ESP) Block in Total Knee Arthroplasty: A Prospective Observational Study
Run by San Giovanni di Dio Hospital · NCT07017400 · Data updated 2026-11-12
This will test whether adding a sacral erector spinae plane (ESP) block to an adductor canal block gives adults having a unilateral knee replacement as good or better pain relief and recovery as adding an iPACK block.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 126 (estimated) |
| Sponsor | San Giovanni di Dio Hospital Academic / other |
| Locations | 1 site (Crotone) |
| Status | Recruiting |
| Started | July 16, 2025 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | August 28, 2025 |
| Trial ID | NCT07017400 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults over 18 years with ASA physical status I–III scheduled for unilateral total knee arthroplasty under spinal anesthesia with expected hospitalization >24 hours.
✕Probably not a fit
Patients with contraindications to spinal or regional anesthesia, active infection, severe dementia, anticoagulation issues, or emergency surgeries are excluded and unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center prospective observational study in Crotone, Italy will follow adults (ASA I–III) undergoing unilateral total knee arthroplasty under spinal anesthesia who receive either adductor canal block (ACB) plus sacral ESP or ACB plus iPACK as part of routine care. Participants will be observed for 48 hours postoperatively and the primary outcome is the QoR-15 score at 24 hours, with pain scores and other recovery measures as secondary endpoints. The planned enrollment is 63 patients per group based on power calculations to detect a meaningful difference in QoR-15. Because the design is observational, clinicians choose the block combination as usual care and investigators record outcomes without altering treatment.
Why it matters
Potential benefit: If successful, the sacral ESP plus ACB approach could provide comparable pain relief with fewer surgical-site risks and less motor weakness, improving safety and recovery after knee replacement.
How similar studies have gone: Early reports and local clinical experience suggest sacral ESP combined with ACB may offer comparable analgesia to ACB plus iPACK, but high-quality comparative data are still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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San Giovanni Crotone Hospital
Crotone, Italy Recruiting
Study contacts
- Study coordinator: Tommaso Sorrentino, Anesthesiology
- Email: tommaso.sorrentino@asp.crotone.it
- Phone: +393277038017
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.