PENG Block and Delirium After Hip Arthroplasty
ConditionHip Osteoarthritis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age75-100
SponsorPoznan University of Medical Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 75 years
Scheduled for elective primary total hip arthroplasty
Planned spinal anesthesia
ASA physical status II-III
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
sham block with 0.9% sodium chloride
DrugAfter spinal anesthesia, the ultrasound-guided PENG block will be performed with 20ml of 0.9% sodium chloride
0.2% ropivacaine
DrugAfter spinal anesthesia, the ultrasound-guided PENG block will be performed with 20 ml of 0.2% ropivacaine
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Sham BlockPlacebo comparator 1 intervention
Group B: PENG blockActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of postoperative delirium
Incidence of postoperative delirium within 72 hours after surgery, defined as at least one positive Confusion Assessment Method (CAM) assessment (CAM+) at any of the prespecified postoperative time points. CAM will be administered by trained assessors blinded to group allocation. The primary endpoint will be recorded as a binary outcome (delirium: yes/no)
Time frame
12 hours after surgerySecondary outcomes
1
Incidence of Postoperative Delirium
Incidence of postoperative delirium within 72 hours after surgery, defined as at least one positive Confusion Assessment Method (CAM) assessment (CAM+) at any of the prespecified postoperative time points. CAM will be administered by trained assessors blinded to group allocation. The primary endpoint will be recorded as a binary outcome (delirium: yes/no)
Time frame
24 hours after surgery2
Incidence of Postoperative Delirium
Incidence of postoperative delirium within 72 hours after surgery, defined as at least one positive Confusion Assessment Method (CAM) assessment (CAM+) at any of the prespecified postoperative time points. CAM will be administered by trained assessors blinded to group allocation. The primary endpoint will be recorded as a binary outcome (delirium: yes/no)
Time frame
48 hours after surgery3
Incidence of Postoperative Delirium
Incidence of postoperative delirium within 72 hours after surgery, defined as at least one positive Confusion Assessment Method (CAM) assessment (CAM+) at any of the prespecified postoperative time points. CAM will be administered by trained assessors blinded to group allocation. The primary endpoint will be recorded as a binary outcome (delirium: yes/no)
Time frame
72 hours after surgery4
Cumulative Postoperative Opioid Consumption (MME)
Total opioid consumption during the first 48 hours after surgery, converted to morphine milligram equivalents (MME). Includes all rescue opioids administered intravenously or orally
Time frame
48 hours after surgerySponsors and contacts
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Source ClinicalTrials.gov