Hip OsteoarthritisNCT07449468
PENG Block and Delirium After Hip Arthroplasty
A study testing 0.2% ropivacaine in people with Hip Osteoarthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 to 100 years
- Conditions the study is for
- Hip Osteoarthritis
- What is being tested?
- 0.2% ropivacaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2026to 30 Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Poznan University of Medical Sciences
Poznan, 62-701
Malgorzata Reysner, M.D. Ph.D., +48 61 873 83 03, mreysner@ump.edu.pl
About this study
Official title: 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
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.
Read more
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.
Read the detailed description
Postoperative delirium is a frequent and serious complication in older adults undergoing major orthopedic surgery, including total hip arthroplasty. Its incidence in this population ranges from 10% to 30% and is associated with prolonged hospital stay, increased healthcare costs, delayed functional recovery, long-term cognitive impairment, and increased mortality. Among modifiable perioperative risk factors, inadequate pain control, higher opioid consumption, postoperative nausea and vomiting, sleep disturbances, delayed mobilization, and systemic inflammatory response play an important role.
Regional anesthesia techniques may reduce delirium risk by improving analgesia, decreasing opioid requirements, and attenuating surgical stress and inflammatory response. The Pericapsular Nerve Group (PENG) block is an ultrasound-guided regional anesthesia technique targeting the articular branches supplying the anterior hip capsule. It has been shown to provide effective analgesia after hip surgery while largely preserving quadriceps motor function, potentially facilitating early mobilization.
This study is a prospective, randomized, parallel-group controlled trial designed to evaluate whether the addition of ultrasound-guided PENG block to spinal anesthesia reduces the incidence of postoperative delirium in patients aged 65 years or older undergoing primary elective total hip arthroplasty.
Eligible patients (ASA II-III) will be randomized in a 1:1 ratio to receive:
spinal anesthesia with standard multimodal postoperative analgesia (control group), or spinal anesthesia combined with ultrasound-guided PENG block plus standard multimodal postoperative analgesia (intervention group).
Randomization will be computer-generated with concealed allocation. Outcome assessors evaluating delirium and functional endpoints will be blinded to group assignment. The anesthesiologist performing the block cannot be blinded but will not participate in postoperative outcome assessment.
The primary endpoint is the incidence of postoperative delirium within 72 hours after surgery, assessed at least once daily using the Confusion Assessment Method (CAM) by trained, blinded personnel. Documentation review for delirium-related symptoms and use of antidelirium medications will complement, but not replace, structured CAM assessment.
Secondary endpoints include cumulative opioid consumption during the first 48 postoperative hours (expressed as morphine milligram equivalents), pain intensity at rest and during movement (Numeric Rating Scale), time to first rescue opioid administration, incidence of postoperative nausea and vomiting, time to first mobilization, and block-related adverse events.
Additionally, perioperative inflammatory response will be explored using routinely collected complete blood count parameters. Neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and monocyte-to-lymphocyte ratio (MLR) will be calculated at predefined time points (baseline, 24 hours, and 48 hours postoperatively). Exploratory analyses will assess associations between these inflammatory indices and postoperative delirium.
The planned sample size is 144 patients (72 per group), calculated to detect a clinically relevant reduction in delirium incidence with 80% power and a two-sided alpha of 0.05, accounting for potential dropouts.
The study will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice principles. Written informed consent will be obtained from all participants prior to enrollment.
- Conditions
- Hip Osteoarthritis
- Being tested
- sham block with 0.9% sodium chloride, 0.2% ropivacaine
- Medical subject headings
- Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sham block with 0.9% sodium chlorideDrug
After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20ml of 0.9% sodium chloride
0.2% ropivacaineDrug
Also called PENG block with 0.2% ropivacaine
After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20 ml of 0.2% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Sham Block | Placebo comparator | PENG block with 20ml of 0.9% sodium chloride Receives: Drug: sham block with 0.9% sodium chloride |
| PENG block | Active comparator | PENG block with 20ml 0f 0.2% ropivacaine Receives: Drug: 0.2% ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 hours after surgery
Secondary outcomes (17)
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)
Measured: 24 hours after surgery
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)
Measured: 48 hours after surgery
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)
Measured: 72 hours after surgery
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
Measured: 48 hours after surgery
Postoperative Pain Intensity (NRS)
Pain intensity assessed using the 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at rest and during movement.
Measured: 4 hours after surgery
Postoperative Pain Intensity (NRS)
Pain intensity assessed using the 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at rest and during movement.
Measured: 8 hours after surgery
Postoperative Pain Intensity (NRS)
Pain intensity assessed using the 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at rest and during movement.
Measured: 12 hours after surgery
Postoperative Pain Intensity (NRS)
Pain intensity assessed using the 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at rest and during movement.
Measured: 24 hours after surgery
Postoperative Pain Intensity (NRS)
Pain intensity assessed using the 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at rest and during movement.
Measured: 48 hours after surgery
Postoperative Pain Intensity (NRS)
Pain intensity assessed using the 11-point Numeric Rating Scale (NRS, 0 = no pain, 10 = worst imaginable pain) at rest and during movement.
Measured: 72 hours after surgery
Time to First Rescue Opioid Administration
Time (in hours) from arrival in the postoperative recovery area to the first administration of rescue opioid analgesia.
Measured: 48 hours after surgery
Incidence of Postoperative Nausea and Vomiting (PONV)
Occurrence of nausea and/or vomiting requiring pharmacological treatment during the early postoperative period.
Measured: 24 hours after surgery
Time to First Mobilization
Time (in hours) from the end of surgery to first assisted mobilization (e.g., standing or ambulation with physiotherapist support).
Measured: 72 hours after surgery
Systemic Inflammation Response Index (SIRI)
Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula:
SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L.
SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.
Measured: 12 hours after surgery
Systemic Inflammation Response Index (SIRI)
Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula:
SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L.
SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.
Measured: 24 hours after surgery
Systemic Inflammation Response Index (SIRI)
Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula:
SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L.
SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.
Measured: 48 hours after surgery
Systemic Inflammation Response Index (SIRI)
Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula:
SIRI = (Neutrophil count × Monocyte count) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L.
SIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.
Measured: 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Mar 2026
- Primary completion1 May 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poznan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449468
- Sponsor's protocol ID
- 87/26
- Status last verified
- Apr 2026
- First submitted
- 27 Feb 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.