Effectiveness of the Sacral Erector Spinae Plane (ESP) Block in Total Knee Arthroplasty: A Prospective Observational Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 126
- Locations
- 1
- Primary Endpoint
- Quality of Recovery (QoR-15) score at 24 hours post-surgery
Study Overview
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.
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:
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •ASA-PS > III
- •ongoing infection
- •emergency surgeries
Outcomes
Primary Outcomes
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
- Postoperative pain scores (NRS) at rest and movement (0-48 hours)(0-48 hours from surgery)
- Analgesic consumption (total drug dosage)(0-48 hours)
- Time to first mobilization(0-48 hours)
- Time to first analgesic request (time - hour - of first request)(0-48 hours)
Investigators
Tommaso Sorrentino
Principal Investigator
San Giovanni di Dio Hospital