PENG Block and Delirium After Hip Arthroplasty
Effect of Pericapsular Nerve Group (PENG) Block Added to Spinal Anesthesia on Postoperative Delirium in Older Adults Undergoing Primary Total Hip Arthroplasty: A Prospective, Randomized, Assessor-Blinded Controlled Trial
1 other identifier
interventional
180
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedFirst Posted
Study publicly available on registry
March 4, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
May 22, 2026
April 1, 2026
1.2 years
February 27, 2026
May 20, 2026
Conditions
Outcome Measures
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)
12 hours after surgery
Secondary Outcomes (17)
Incidence of Postoperative Delirium
24 hours after surgery
Incidence of Postoperative Delirium
48 hours after surgery
Incidence of Postoperative Delirium
72 hours after surgery
Cumulative Postoperative Opioid Consumption (MME)
48 hours after surgery
Postoperative Pain Intensity (NRS)
4 hours after surgery
- +12 more secondary outcomes
Study Arms (2)
Sham Block
PLACEBO COMPARATORPENG block with 20ml of 0.9% sodium chloride
PENG block
ACTIVE COMPARATORPENG block with 20ml 0f 0.2% ropivacaine
Interventions
After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20ml of 0.9% sodium chloride
After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20 ml of 0.2% ropivacaine
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Poznan University of Medical Sciences
Poznan, 62-701, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2026
First Posted
March 4, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
May 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Data will become available 6 months after publication of the primary results and will remain available for 5 years.
- Access Criteria
- A methodologically sound research proposal Institutional affiliation Ethical approval (if required) A signed data use agreement Requests should be directed to the principal investigator via institutional email.
De-identified individual participant data (IPD) underlying the results reported in publications (including demographic data, laboratory inflammatory indices such as SII, SIRI, AISI, CRP values, pain scores, opioid consumption, and time-to-event outcomes) will be made available to qualified researchers. Data will be shared after removal of all direct identifiers in accordance with GDPR regulations and institutional data protection policies. The study protocol, statistical analysis plan (SAP), and analytic code will also be available upon reasonable request. Data will be provided for the purpose of secondary analyses, meta-analyses, or validation studies, subject to approval by the principal investigator and institutional review board, where applicable.