PENG Block and Delirium After Hip Arthroplasty
Recruiting · NCT07449468 · Interventional (participants receive a specific treatment) · Lead sponsor: Poznan University of Medical Sciences
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Postoperative delirium is a common and serious complication in older adults undergoing total hip arthroplasty, associated with prolonged hospitalization, increased morbidity, delayed rehabilitation, and long-term cognitive decline. Modifiable perioperative risk factors include uncontrolled postoperative pain, opioid consumption, impaired early mobilization, and systemic inflammatory response. The Pericapsular Nerve Group (PENG) block is a regional anesthesia technique targeting the sensory innervation of the anterior hip capsule and may provide effective analgesia while preserving motor function. Improved pain control and opioid reduction may decrease the incidence of postoperative delirium. This prospective, randomized, parallel-group controlled trial aims to evaluate whether the addition of ultrasound-guided PENG block to spinal anesthesia reduces the incidence of postoperative delirium within 72 hours after primary total hip arthroplasty in patients aged 65 years or older. Delirium will be assessed using the Confusion Assessment Method (CAM) by blinded outcome assessors. Secondary outcomes include postoperative opioid consumption, pain intensity (NRS), time to first rescue opioid, postoperative nausea and vomiting, time to mobilization, block-related adverse events, and perioperative inflammatory indices (neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, and monocyte-to-lymphocyte ratio). The study will enroll 144 patients randomized 1:1 to spinal anesthesia alone or spinal anesthesia plus PENG block.
Who can take part
Inclusion criteria
- Age ≥ 75 years
- Scheduled for elective primary total hip arthroplasty
- Planned spinal anesthesia
- ASA physical status II-III
- Ability to provide written informed consent
- Ability to communicate and reliably assess pain using the Numeric Rating Scale (NRS)
- Expected postoperative hospitalization ≥ 72 hours
Exclusion criteria
- Pre-existing delirium, acute psychosis, or active major psychiatric disorder
- Documented severe dementia or inability to provide informed consent
- Severe hearing or visual impairment preventing reliable CAM assessment
- Contraindications to regional anesthesia (e.g., coagulopathy according to institutional standards, infection at the injection site, allergy to local anesthetics)
- Pre-existing neurological deficits of the operative lower limb are interfering with assessment
- Chronic opioid use (\>30 mg morphine milligram equivalents per day for \>2 weeks prior to surgery)
- Severe renal impairment (eGFR \<30 mL/min/1.73 m²)
- Severe hepatic insufficiency
- Participation in another interventional clinical trial within 30 days
- Any other condition that, in the investigator's judgment, may interfere with study participation or protocol adherence
Where it is running
1 location listed.
- Poznan University of Medical Sciences - Poznan, Poland