PENG Block and Delirium After Hip Arthroplasty

NCT07449468 · tracked via the Priya Life Science Poland tracker

Sponsor

Poznan University of Medical Sciences

Phase

Not applicable

Started

2026-03-01

Last updated

2026-05-22

Condition(s) studied

Hip Osteoarthritis

Investigational drug(s) / intervention(s)

sham block with 0.9% sodium chloride0.2% ropivacaine →

sham block with 0.9% sodium chloride: After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20ml of 0.9% sodium chloride

0.2% ropivacaine: After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20 ml of 0.2% ropivacaine

Study summary

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

Sex

ALL

Min age

75 Years

Max age

100 Years

Healthy volunteers

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

Primary outcome measure(s)

Incidence of postoperative delirium — 12 hours after surgery
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)

Trial sites (1)

Facility	City	Region	Status
Poznan University of Medical Sciences	Poznan	Poland	Recruiting

More Poznan University of Medical Sciences trials in Poland

Polish Multicenter PERTs PE Outcomes Registry Recruiting

Dexamethasone vs Dexmedetomidine vs Combination as Adjuvants to Popliteal Sciatic Nerve Block in Children Recruiting

Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty Starting soon

The Hypotension Prediction Index Versus Standard Advanced Haemodynamic Monitoring in Patients Undergoing Major Aortic Surgery Recruiting

Diaphragm-Sparing Regional Anesthesia Techniques for Shoulder Surgery Recruiting

Other trials for the same condition

Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty Starting soon

PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty Recruiting

SII Levels Following PENG Block in Hip Arthroplasty Recruiting

Intravenous Dexamethasone (0 vs 4 vs 8 mg) as an Adjunct to PENG Block for Postoperative Analgesia in Total Hip Arthroplasty: A Randomized Double-Blind Trial Recruiting

Molecular Mechanisms Underlying Hip and Knee Osteoarthritis in Patients Undergoing Primary Elective Arthroplasty Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07449468 on ClinicalTrials.gov ↗ ← All trials in Poland