Sacral ESP plus adductor canal block versus iPACK plus adductor canal block for pain control after knee replacement
Effectiveness of the Sacral Erector Spinae Plane (ESP) Block in Total Knee Arthroplasty: A Prospective Observational Study
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 |
|---|---|
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | San Giovanni di Dio Hospital Academic / other |
| Locations | 1 site (Crotone) |
| Trial ID | NCT07017400 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Crotone
- San Giovanni Crotone Hospital — Crotone, Italy (Recruiting)
Study contacts
- Study coordinator: Tommaso Sorrentino, Anesthesiology
- Email: tommaso.sorrentino@asp.crotone.it
- Phone: +393277038017
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.