Hip OstearthritisPENG neuromoduNCT07925658
Autonomic and Immune Effects of Regional Anesthesia in Total Hip Arthroplasty
A study testing PENG Block and LIA in people with Hip Ostearthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
Trial summary
Surgical trauma activates the sympathetic nervous system and induces a systemic inflammatory response, both of which may adversely affect postoperative recovery. Regional anesthesia has traditionally been used for perioperative analgesia; however, emerging evidence suggests that peripheral nerve blocks may also… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Hip Ostearthritis
- What is being tested?
- PENG Block and LIA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2026to 1 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged ≥18 years.
- Scheduled for elective primary total hip arthroplasty due to primary hip osteoarthritis.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Planned spinal anesthesia with one of the study regional analgesia techniques.
- Ability to understand the study procedures and provide written informed consent.
Who cannot join
- Refusal or inability to provide written informed consent.
- Revision hip arthroplasty, simultaneous bilateral hip arthroplasty, or hip arthroplasty performed for an acute fracture.
- Known hypersensitivity to ropivacaine or other medications required for the study procedures.
- Contraindication to spinal anesthesia, PENG block, or local infiltration analgesia, including infection at the injection site or a coagulation disorder or antithrombotic treatment that precludes safe performance of the planned procedures.
- Pre-existing neurological or neuromuscular disease that substantially affects sensation or motor function in the operated limb or prevents reliable assessment of study outcomes.
- Cognitive impairment or a communication disorder that prevents understanding of the study procedures or reliable completion of pain assessments.
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- A medical condition that, in the investigator's judgment, makes participation or the planned anesthetic procedures unsafe.
- Planned use of an additional regional analgesic technique outside the study protocol.
- Participation in another interventional study that could interfere with the assessment of the study outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effects of Three Regional Anesthesia Strategies on Autonomic Regulation, Systemic Inflammatory Response, and Postoperative Recovery Following Elective Total Hip Arthroplasty: A Prospective Randomized Double-Blind Trial
Surgical trauma activates the sympathetic nervous system and induces a systemic inflammatory response, both of which may adversely affect postoperative recovery. Regional anesthesia has traditionally been used for perioperative analgesia; however, emerging evidence suggests that peripheral nerve blocks may also modulate autonomic and immune pathways. This prospective randomized double-blind trial aims to compare three regional anesthesia strategies in patients undergoing elective total hip arthroplasty under spinal anesthesia and to determine their effects on autonomic regulation, systemic inflammatory response, postoperative pain, opioid consumption, quality of recovery, and early functional outcomes.
Read the detailed description
Total hip arthroplasty (THA) is associated with substantial surgical trauma, resulting in activation of the sympathetic nervous system and a systemic inflammatory response that may contribute to postoperative pain, delayed functional recovery, and perioperative complications. Although regional anesthesia techniques are widely used to improve postoperative analgesia, increasing evidence suggests that they may also influence autonomic regulation and neuroimmune interactions beyond their analgesic effects. The extent to which different regional anesthesia strategies modify perioperative autonomic and inflammatory responses remains incompletely understood.
This prospective, randomized, double-blind, controlled trial aims to compare three regional analgesic strategies in patients undergoing elective primary total hip arthroplasty under spinal anesthesia: ultrasound-guided pericapsular nerve group (PENG) block, local infiltration analgesia (LIA), and the combination of PENG block with LIA. All patients will receive standardized perioperative anesthetic and multimodal analgesic management, with the regional analgesic technique being the only study intervention.
The primary objective is to determine whether different regional anesthesia strategies differentially influence perioperative autonomic regulation and systemic inflammatory response. Autonomic function will be assessed using perioperative hemodynamic parameters and vasopressor requirements, while systemic inflammatory activation will be evaluated using routinely available inflammatory biomarkers, including the Systemic Immune-Inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), and other laboratory markers measured before and after surgery.
Secondary objectives include comparison of postoperative pain intensity at rest and during movement, opioid consumption, time to first rescue analgesia, quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire, incidence of postoperative nausea and vomiting, time to first ambulation, length of hospital stay, patient satisfaction, and the incidence of postoperative complications.
The study is designed to determine whether combining peripheral nerve blockade with periarticular infiltration provides additive benefits not only for postoperative analgesia but also for modulation of autonomic-immune interactions and enhancement of postoperative recovery. The findings may improve understanding of peripheral nerve blocks as a form of perioperative neuromodulation and support optimization of regional anesthesia strategies in patients undergoing total hip arthroplasty.
- Conditions
- Hip Ostearthritis
- Being tested
- PENG Block, LIA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENG BlockDrug
Also called PENG, Pericapsular Nerve Group Block, 0.2% Ropimol
Ultrasound-guided single-injection pericapsular nerve group (PENG) block performed before surgery using 20ml of 0.2% ropivacaine
LIADrug
Also called Periarticular Infiltration Analgesia, 0.2% ropimol
Local infiltration analgesia is performed intraoperatively - 20ml 0.2% ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| PENG Block | Experimental | Ropivacaine for Pericapsular Nerve Group (PENG) Block Receives: Drug: PENG Block |
| Local Infiltration Analgesia (LIA) | Experimental | Ropivacaine for Local Infiltration Analgesia Receives: Drug: LIA |
| Combined PENG Block + LIA | Experimental | Ropivacaine for Pericapsular Nerve Group (PENG) block before surgery and Local Infiltration Analgesia (LIA) Receives: Drug: PENG Block; Drug: LIA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systemic Immune-Inflammation Index (SII)
Comparison of the change in Systemic Immune-Inflammation Index from baseline to postoperative 24 hours among the three study groups.
Measured: 24 hours after surgery
Secondary outcomes (24)
Neutrophil-to-Lymphocyte Ratio (NLR)
Comparison of the change in neutrophil-to-lymphocyte ratio among the three study groups.
Measured: 24 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Comparison of the change in neutrophil-to-lymphocyte ratio among the three study groups.
Measured: 12 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Comparison of the change in neutrophil-to-lymphocyte ratio among the three study groups.
Measured: 48 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Comparison of the change in platelet-to-lymphocyte ratio among the three study groups.
Measured: 24 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Comparison of the change in platelet-to-lymphocyte ratio among the three study groups.
Measured: 48 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Comparison of the change in platelet-to-lymphocyte ratio among the three study groups.
Measured: 12 hours after surgery
Postoperative pain intensity
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
Measured: 2 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement.
Measured: 2 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement.
Measured: 6 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement.
Measured: 12 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement.
Measured: 24 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at movement.
Measured: 48 hours after surgery
Postoperative pain intensity
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
Measured: 6 hours after surgery
Postoperative pain intensity
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
Measured: 12 hours after surgery
Postoperative pain intensity
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
Measured: 24 hours after surgery
Postoperative pain intensity
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
Measured: 48 hours after surgery
Postoperative opioid consumption
Comparison of cumulative opioid consumption during the postoperative period, expressed as intravenous morphine milligram equivalents (MME).
Measured: 48 hours after surgery
Time to first rescue analgesia
Comparison of the time from the end of surgery to the first administration of rescue opioid analgesia.
Measured: 48 hours after surgery
Systemic Immune-Inflammation Index (SII)
Comparison of the change in the Systemic Immune-Inflammation Index (SII) among the three study groups.
Measured: 24 hours after surgery
Systemic Immune-Inflammation Index (SII)
Comparison of the change in the Systemic Immune-Inflammation Index (SII) among the three study groups.
Measured: 12 hours after surgery
Systemic Immune-Inflammation Index (SII)
Comparison of the change in the Systemic Immune-Inflammation Index (SII) among the three study groups.
Measured: 48 hours after surgery
C-reactive protein (CRP)
Comparison of postoperative C-reactive protein (CRP) concentrations among the three study groups.
Measured: 12 hours after surgery
C-reactive protein (CRP)
Comparison of postoperative C-reactive protein (CRP) concentrations among the three study groups.
Measured: 24 hours after surgery
C-reactive protein (CRP)
Comparison of postoperative C-reactive protein (CRP) concentrations among the three study groups.
Measured: 48 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 posted9 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip OstearthritisStudies 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
- 165 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
- NCT07925658
- Sponsor's protocol ID
- 18/2026
- Acronym
- PENG neuromodu
- Status last verified
- Nov 2026
- First submitted
- 29 Jul 2026
- Last updated
- 9 Nov 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 underlying the published results will be made available upon reasonable request to the corresponding author. Data will be shared after publication of the primary study results and following approval of a methodologically sound research proposal and completion of a data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Three Regional Anesthesia Strategies on Autonomic Regulation, Systemic Inflammatory Response, and Postoperative Recovery Following Elective Total Hip Arthroplasty: A Prospective Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT07925658
- Acronym / sponsor ID
- PENG neuromodu / 18/2026
- Conditions
- Hip Ostearthritis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Poznan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 9 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Surgical trauma activates the sympathetic nervous system and induces a systemic inflammatory response, both of which may adversely affect postoperative recovery. Regional anesthesia has traditionally been used for perioperative analgesia; however, emerging evidence suggests that peripheral nerve blocks may also modulate autonomic and immune pathways. This prospective randomized double-blind trial aims to compare three regional anesthesia strategies in patients undergoing elective total hip arthroplasty under spinal anesthesia and to determine their effects on autonomic regulation, systemic inflammatory response, postoperative pain, opioid consumption, quality of recovery, and early functional outcomes.
Detailed description
Total hip arthroplasty (THA) is associated with substantial surgical trauma, resulting in activation of the sympathetic nervous system and a systemic inflammatory response that may contribute to postoperative pain, delayed functional recovery, and perioperative complications. Although regional anesthesia techniques are widely used to improve postoperative analgesia, increasing evidence suggests that they may also influence autonomic regulation and neuroimmune interactions beyond their analgesic effects. The extent to which different regional anesthesia strategies modify perioperative autonomic and inflammatory responses remains incompletely understood.
This prospective, randomized, double-blind, controlled trial aims to compare three regional analgesic strategies in patients undergoing elective primary total hip arthroplasty under spinal anesthesia: ultrasound-guided pericapsular nerve group (PENG) block, local infiltration analgesia (LIA), and the combination of PENG block with LIA. All patients will receive standardized perioperative anesthetic and multimodal analgesic management, with the regional analgesic technique being the only study intervention.
The primary objective is to determine whether different regional anesthesia strategies differentially influence perioperative autonomic regulation and systemic inflammatory response. Autonomic function will be assessed using perioperative hemodynamic parameters and vasopressor requirements, while systemic inflammatory activation will be evaluated using routinely available inflammatory biomarkers, including the Systemic Immune-Inflammation Index (SII), neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), and other laboratory markers measured before and after surgery.
Secondary objectives include comparison of postoperative pain intensity at rest and during movement, opioid consumption, time to first rescue analgesia, quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire, incidence of postoperative nausea and vomiting, time to first ambulation, length of hospital stay, patient satisfaction, and the incidence of postoperative complications.
The study is designed to determine whether combining peripheral nerve blockade with periarticular infiltration provides additive benefits not only for postoperative analgesia but also for modulation of autonomic-immune interactions and enhancement of postoperative recovery. The findings may improve understanding of peripheral nerve blocks as a form of perioperative neuromodulation and support optimization of regional anesthesia strategies in patients undergoing total hip arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PENG Block | Experimental | Drug: PENG BlockRopivacaine for Pericapsular Nerve Group (PENG) Block |
| Local Infiltration Analgesia (LIA) | Experimental | Drug: LIARopivacaine for Local Infiltration Analgesia |
| Combined PENG Block + LIA | Experimental | Drug: PENG Block, Drug: LIARopivacaine for Pericapsular Nerve Group (PENG) block before surgery and Local Infiltration Analgesia (LIA) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged ≥18 years.
- Scheduled for elective primary total hip arthroplasty due to primary hip osteoarthritis.
- American Society of Anesthesiologists (ASA) physical status I-III.
- Planned spinal anesthesia with one of the study regional analgesia techniques.
- Ability to understand the study procedures and provide written informed consent.
Key exclusion criteria (9 listed)
- Refusal or inability to provide written informed consent.
- Revision hip arthroplasty, simultaneous bilateral hip arthroplasty, or hip arthroplasty performed for an acute fracture.
- Known hypersensitivity to ropivacaine or other medications required for the study procedures.
- Contraindication to spinal anesthesia, PENG block, or local infiltration analgesia, including infection at the injection site or a coagulation disorder or antithrombotic treatment that precludes safe performance of the planned procedures.
- Pre-existing neurological or neuromuscular disease that substantially affects sensation or motor function in the operated limb or prevents reliable assessment of study outcomes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PENG BlockAlso: PENG, Pericapsular Nerve Group Block, 0.2% RopimolUltrasound-guided single-injection pericapsular nerve group (PENG) block performed before surgery using 20ml of 0.2% ropivacaine | Drug | Combined PENG Block + LIA, PENG Block |
| LIAAlso: Periarticular Infiltration Analgesia, 0.2% ropimolLocal infiltration analgesia is performed intraoperatively - 20ml 0.2% ropivacaine | Drug | Combined PENG Block + LIA, Local Infiltration Analgesia (LIA) |
Primary outcome
Change in Systemic Immune-Inflammation Index (SII)
Time frame: 24 hours after surgery
Comparison of the change in Systemic Immune-Inflammation Index from baseline to postoperative 24 hours among the three study groups.
24 secondary outcomes
Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: 24 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: 12 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: 48 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Time frame: 24 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Time frame: 48 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Time frame: 12 hours after surgery
Postoperative pain intensity
Time frame: 2 hours after surgery
Postoperative pain intensity at movement
Time frame: 2 hours after surgery
Postoperative pain intensity at movement
Time frame: 6 hours after surgery
Postoperative pain intensity at movement
Time frame: 12 hours after surgery
Postoperative pain intensity at movement
Time frame: 24 hours after surgery
Postoperative pain intensity at movement
Time frame: 48 hours after surgery
Postoperative pain intensity
Time frame: 6 hours after surgery
Postoperative pain intensity
Time frame: 12 hours after surgery
Postoperative pain intensity
Time frame: 24 hours after surgery
Postoperative pain intensity
Time frame: 48 hours after surgery
Postoperative opioid consumption
Time frame: 48 hours after surgery
Time to first rescue analgesia
Time frame: 48 hours after surgery
Systemic Immune-Inflammation Index (SII)
Time frame: 24 hours after surgery
Systemic Immune-Inflammation Index (SII)
Time frame: 12 hours after surgery
Systemic Immune-Inflammation Index (SII)
Time frame: 48 hours after surgery
C-reactive protein (CRP)
Time frame: 12 hours after surgery
C-reactive protein (CRP)
Time frame: 24 hours after surgery
C-reactive protein (CRP)
Time frame: 48 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results will be made available upon reasonable request to the corresponding author. Data will be shared after publication of the primary study results and following approval of a methodologically sound research proposal and completion of a data sharing agreement.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENG Block and LIA in people with Hip Ostearthritis, run by Poznan University of Medical Sciences at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Malgorzata Reysner, MD PhD (+48 61 8310122, mreysner@ump.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systemic Immune-Inflammation Index (SII) (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.