San Giovanni Crotone Hospital
Crotone, Italy
Location status: Recruiting
Location contact
Tommaso Sorrentino, M.D.
CONTACT
NCT Number: NCT07017400
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Crotone, Italy
Location status: Recruiting
Tommaso Sorrentino, M.D.
CONTACT
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:
Population:
Primary Endpoint:
Secondary Endpoints:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
combination of regional blocks for TKA postoperative analgesia
Time frame: at 24 hours post-surgery
Quality of Recovery (QoR-15) - score range 0-150 - higher scores indicate better recovery
Time frame: 0-48 hours from surgery
NRS at rest and movement - score range 0 (no pain) - 10 (the worst pain)
Time frame: 0-48 hours
first patient mobilization - time (hour) of first mobilization
Time frame: 0-48 hours
Effectiveness of the blocks
Time frame: 0-48 hours
Duration of the blocks
Contact information is provided by the study sponsor or research team.
San Giovanni di Dio Hospital
Other
Effectiveness of the Sacral Erector Spinae Plane (ESP) Block in Total Knee Arthroplasty: A Prospective Observational Study
Acronym: sacral ESP
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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