About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 50-90 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 combined with ultrasound-guided Pericapsular Nerve Group (PENG) block.
Disqualifiers
Refusal to participate or inability to provide written informed consent.
Contraindications to spinal anesthesia.
Contraindications to PENG block.
Allergy or hypersensitivity to dexmedetomidine, ropivacaine, bupivacaine, or study medications.
Trial design
Parallel
Treatments tested in this trial
Placebo
DrugIntravenous 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.
Dexmedetomidine
DrugIntravenous 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.
Dexmedetomidine
DrugIntravenous 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.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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
Neutrophil-to-Lymphocyte Ratio (NLR)
Neutrophil-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts
Neutrophil-to-Lymphocyte Ratio (NLR)
Neutrophil-to-lymphocyte ratio (NLR), calculated from routine peripheral blood counts
Sponsors and contacts
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