An interventional study of Placebo and Dexmedetomidine in Hip Osteoarthritis, sponsored by Poznan University of Medical Sciences. Recruiting at 1 site in Poland. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Poznan University of Medical Sciences · Not applicable, Interventional, and Treatment
Surgical trauma induces activation of the sympathetic nervous system and triggers a systemic inflammatory response that may adversely affect postoperative recovery. Dexmedetomidine, a highly selective α2-adrenoceptor agonist, has been proposed as a pharmacological neuromodulatory strategy capable of attenuating sympathetic activation and modulating neuroimmune interactions during the perioperative period. However, the extent to which intravenous dexmedetomidine influences perioperative inflammatory biomarkers and clinical recovery in patients undergoing total hip arthroplasty under regional anesthesia remains unclear.
This prospective, randomized, double-blind, placebo-controlled trial aims to evaluate the effects of two doses of intravenous dexmedetomidine administered during spinal anesthesia combined with ultrasound-guided pericapsular nerve group (PENG) block on autonomic regulation, systemic inflammatory response, postoperative pain, opioid consumption, and quality of recovery following elective primary total hip arthroplasty.
Total hip arthroplasty is associated with substantial surgical stress resulting in activation of the sympathetic nervous system, neuroendocrine stress pathways, and systemic inflammation. Excessive perioperative autonomic activation contributes to inflammatory dysregulation, postoperative pain, opioid requirements, delayed functional recovery, and postoperative complications. Strategies capable of attenuating this autonomic stress response may therefore improve postoperative outcomes beyond conventional analgesia.
Dexmedetomidine is a highly selective α2-adrenoceptor agonist with sedative, analgesic, sympatholytic, and anti-inflammatory properties. Experimental and clinical evidence suggests that intravenous dexmedetomidine may reduce sympathetic outflow, attenuate neuroendocrine stress responses, modulate cytokine release, and preserve autonomic homeostasis during the perioperative period. Nevertheless, prospective randomized studies evaluating its effects on both autonomic regulation and systemic inflammatory response in patients receiving contemporary regional anesthesia remain limited.
This prospective, randomized, double-blind, placebo-controlled trial will compare three perioperative strategies in patients undergoing elective primary total hip arthroplasty under spinal anesthesia combined with ultrasound-guided PENG block:
placebo, low-dose intravenous dexmedetomidine, high-dose intravenous dexmedetomidine. All patients will receive identical surgical, anesthetic, and multimodal analgesic management. Intravenous dexmedetomidine administration will constitute the only study intervention.
The primary objective is to determine whether intravenous dexmedetomidine attenuates the perioperative systemic inflammatory response as assessed by changes in the Systemic Immune-Inflammation Index (SII). Secondary objectives include evaluation of additional inflammatory biomarkers including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), C-reactive protein (CRP), monocyte-to-lymphocyte ratio (MLR), Systemic Inflammation Response Index (SIRI), and Aggregate Index of Systemic Inflammation (AISI), together with perioperative hemodynamic stability, vasopressor requirements, postoperative pain intensity, opioid consumption, time to first rescue analgesia, quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire, postoperative nausea and vomiting, time to first ambulation, length of hospital stay, patient satisfaction, and postoperative complications.
The study is designed to investigate intravenous dexmedetomidine as a perioperative pharmacological autonomic-immune neuromodulatory strategy rather than solely an analgesic adjuvant. The findings may improve understanding of the relationship between autonomic regulation, systemic inflammation, and postoperative recovery, and contribute to optimization of perioperative multimodal anesthesia for patients undergoing total hip arthroplasty.
641 studies on the registry are indexed under Osteoarthritis, Hip; 120 are open to participants now.
This study's planned enrollment of 90 is close to the median of 90 across 457 interventional studies indexed under Osteoarthritis, Hip.
Browse Osteoarthritis, Hip studies →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.
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.
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 score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
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.
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.
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.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive intravenous placebo (0.9% saline) administered according to the study protocol during elective primary total hip arthroplasty performed under spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block. All participants will receive identical perioperative management and multimodal analgesia. Intravenous placebo is the only study intervention differing between groups.
Drug: Placebo
Participants will receive low-dose intravenous dexmedetomidine administered according to the study protocol during elective primary total hip arthroplasty performed under spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block. All participants will receive identical perioperative management and multimodal analgesia. Intravenous dexmedetomidine dose is the only study intervention differing between groups.
Drug: Dexmedetomidine
Participants will receive high-dose intravenous dexmedetomidine administered according to the study protocol during elective primary total hip arthroplasty performed under spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block. All participants will receive identical perioperative management and multimodal analgesia. Intravenous dexmedetomidine dose is the only study intervention differing between groups.
Drug: Dexmedetomidine
Intravenous administration of 0.9% saline according to the study protocol during elective primary total hip arthroplasty performed under spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block. The placebo solution will be identical in appearance and volume to dexmedetomidine to maintain blinding.
Intravenous dexmedetomidine administered according to the randomized study protocol during elective primary total hip arthroplasty performed under spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block. Participants will receive low-dose dexmedetomidine according to group allocation.
Intravenous dexmedetomidine administered according to the randomized study protocol during elective primary total hip arthroplasty performed under spinal anesthesia combined with ultrasound-guided Pericapsular Nerve Group (PENG) block. Participants will receive high-dose dexmedetomidine according to group allocation.
Change in the Systemic Immune-Inflammation Index (SII)
Comparison of the change in the Systemic Immune-Inflammation Index (SII) from baseline to 24 hours after surgery among the three study groups.
Time frame: 24 24 hours after surgery
Change in Systemic Immune-Inflammation Index (SII)
Comparison of the change in the Systemic Immune-Inflammation Index (SII) from baseline to 12 hours after surgery
Time frame: 12 hours after surgery
Change in Systemic Immune-Inflammation Index (SII)
Comparison of the change in the Systemic Immune-Inflammation Index (SII) from baseline to 48 hours after surgery
Time frame: 48 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Neutrophil-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts
Time frame: 12 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Neutrophil-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts
Time frame: 24 hours after surgery
Neutrophil-to-Lymphocyte Ratio (NLR)
Neutrophil-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts
Time frame: 48 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Platelet-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts
Time frame: 12 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Platelet-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts
Time frame: 24 hours after surgery
Platelet-to-Lymphocyte Ratio (PLR)
Platelet-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts
Time frame: 48 hours after surgery
C-reactive protein (CRP)
postoperative C-reactive protein (CRP) concentrations
Time frame: 24 hours after surgery
Postoperative opioid consumption
Cumulative postoperative opioid consumption expressed as intravenous morphine milligram equivalents (MME).
Time frame: 48 hours after surgery
Time to first rescue opioid analgesia
Comparison of the time from the end of surgery to the first administration of rescue opioid analgesia among the three study groups.
Time frame: 48 hours after surgery
QoR-15
Comparison of postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire among the three study groups.
Time frame: 24 hours after surgery
QoR-15
Comparison of postoperative quality of recovery assessed using the Quality of Recovery-15 (QoR-15) questionnaire among the three study groups.
Time frame: 48 hours after surgery
Postoperative pain intensity at rest
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Time frame: 2 hours after surgery
Postoperative pain intensity at rest
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Time frame: 6 hours after surgery
Postoperative pain intensity at rest
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Time frame: 12 hours after surgery
Postoperative pain intensity at rest
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Time frame: 24 hours after surgery
Postoperative pain intensity at rest
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Time frame: 48 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Time frame: 2 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Time frame: 6 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Time frame: 12 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Time frame: 24 hours after surgery
Postoperative pain intensity at movement
Comparison of postoperative pain intensity at rest assessed using the 11-point Numeric Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst pain imaginable, among the three study groups.
Time frame: 48 hours after surgery
Incidence of postoperative nausea and vomiting
Comparison of the incidence of postoperative nausea and vomiting (PONV) within the first 48 hours after surgery among the three study groups.
Time frame: 48 haours after surgery
Intraoperative vasopressor requirement
Comparison of cumulative vasopressor requirements administered to maintain adequate arterial blood pressure during surgery.
Time frame: durring surgery
Incidence of intraoperative hypotension
Comparison of the incidence of intraoperative hypotension defined as a mean arterial pressure below 65 mmHg requiring therapeutic intervention.
Time frame: durring surgery
Systemic Inflammation Response Index (SIRI)
Comparison of the Systemic Inflammation Response Index (SIRI), calculated from routine peripheral blood counts, among the three study groups as a marker of the perioperative systemic inflammatory response.
Time frame: 24 hours after surgery
Systemic Inflammation Response Index (SIRI)
Comparison of the Systemic Inflammation Response Index (SIRI), calculated from routine peripheral blood counts, among the three study groups as a marker of the perioperative systemic inflammatory response.
Time frame: 48 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Comparison of the Aggregate Index of Systemic Inflammation (AISI), calculated from routine peripheral blood counts, among the three study groups as a marker of the perioperative systemic inflammatory response.
Time frame: 24 hours after surgery
Aggregate Index of Systemic Inflammation (AISI)
Comparison of the Aggregate Index of Systemic Inflammation (AISI), calculated from routine peripheral blood counts, among the three study groups as a marker of the perioperative systemic inflammatory response.
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 following approval of a methodologically sound research proposal and completion of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available beginning 6 months after publication of the primary study results and will remain available for 5 years.
Access criteria: Researchers who provide a scientifically sound research proposal consistent with the objectives of the original study will be granted access to de-identified individual participant data, study protocol, statistical analysis plan, and analytic code. Requests should be submitted to the corresponding author. Access will be granted following approval of the research proposal and execution of a data sharing agreement to ensure appropriate use of the shared data.
No publications or documents are linked to this record.
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