An interventional study of PENG Block and LIA in Hip Ostearthritis, sponsored by Poznan University of Medical Sciences. Not yet recruiting at 1 site in Poland. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Poznan University of Medical Sciences · Not applicable, Interventional, and Treatment
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.
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.
Poznan University of Medical Sciences is the lead sponsor of 151 studies on the registry; 41 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ropivacaine for Pericapsular Nerve Group (PENG) Block
Drug: PENG Block
Ropivacaine for Local Infiltration Analgesia
Drug: LIA
Ropivacaine for Pericapsular Nerve Group (PENG) block before surgery and Local Infiltration Analgesia (LIA)
Drug: PENG Block · Drug: LIA
Ultrasound-guided single-injection pericapsular nerve group (PENG) block performed before surgery using 20ml of 0.2% ropivacaine
Also known as: PENG, Pericapsular Nerve Group Block, 0.2% Ropimol
Local infiltration analgesia is performed intraoperatively - 20ml 0.2% ropivacaine
Also known as: Periarticular Infiltration Analgesia, 0.2% ropimol
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.
Time frame: 24 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Comparison of the change in neutrophil-to-lymphocyte ratio among the three study groups.
Time frame: 24 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Comparison of the change in neutrophil-to-lymphocyte ratio among the three study groups.
Time frame: 12 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Comparison of the change in neutrophil-to-lymphocyte ratio among the three study groups.
Time frame: 48 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Comparison of the change in platelet-to-lymphocyte ratio among the three study groups.
Time frame: 24 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Comparison of the change in platelet-to-lymphocyte ratio among the three study groups.
Time frame: 48 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Comparison of the change in platelet-to-lymphocyte ratio among the three study groups.
Time frame: 12 hours after surgery
Postoperative pain intensity
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 48 hours after surgery
Postoperative pain intensity
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
Time frame: 6 hours after surgery
Postoperative pain intensity
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
Time frame: 12 hours after surgery
Postoperative pain intensity
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
Time frame: 24 hours after surgery
Postoperative pain intensity
Comparison of postoperative pain intensity assessed using the Numeric Rating Scale (NRS; 0-10) at rest.
Time frame: 48 hours after surgery
Postoperative opioid consumption
Comparison of cumulative opioid consumption during the postoperative period, expressed as intravenous morphine milligram equivalents (MME).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 48 hours after surgery
C-reactive protein (CRP)
Comparison of postoperative C-reactive protein (CRP) concentrations among the three study groups.
Time frame: 12 hours after surgery
C-reactive protein (CRP)
Comparison of postoperative C-reactive protein (CRP) concentrations among the three study groups.
Time frame: 24 hours after surgery
C-reactive protein (CRP)
Comparison of postoperative C-reactive protein (CRP) concentrations among the three study groups.
Time frame: 48 hours after surgery
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan, Analytic code
Time frame: Data will be available beginning 6 months after publication of the primary results and for a period of 5 years.
Access criteria: Researchers who provide a methodologically sound proposal aimed at achieving the objectives of the approved proposal will be granted access. Requests should be directed to the corresponding author. A data access agreement will be required prior to data release.
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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