Pericapsular Nerve Group Block Mitigates Surgical Stress and Enhances Analgesia in Total Hip Arthroplasty: A Randomized Controlled Trial
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Poznan University of Medical Sciences
- 入组人数
- 60
- 主要终点
- Systemic Inflammation Response Index (SIRI)
概览
简要总结
This randomized controlled trial evaluates the effect of ultrasound-guided Pericapsular Nerve Group (PENG) block on the Systemic Immune-Inflammation Index (SII) in elderly patients undergoing total hip arthroplasty under spinal anesthesia. SII, calculated as platelet × neutrophil / lymphocyte count, is used as a composite marker of perioperative inflammatory and immune response. The study investigates whether PENG block attenuates the systemic inflammatory reaction to surgical trauma compared to sham block.
详细描述
Surgical trauma induces a systemic inflammatory response characterized by neutrophilia, lymphopenia, and platelet activation. These hematologic alterations reflect the interaction between innate immune activation, stress-induced immunosuppression, and pro-thrombotic mechanisms. The modulation of this response may influence postoperative recovery and complication risk.
The Systemic Immune-Inflammation Index (SII) is calculated using the formula:
SII = (Platelet count × Neutrophil count) / Lymphocyte count SII integrates three components of systemic inflammation and immune regulation and is considered a more comprehensive marker than isolated ratios such as neutrophil-to-lymphocyte ratio (NLR) or platelet-to-lymphocyte ratio (PLR). Compared with NLR and PLR, SII may better reflect the balance between inflammatory activation and adaptive immune suppression in the perioperative period.
Regional anesthesia techniques, including the Pericapsular Nerve Group (PENG) block, may attenuate surgical stress by reducing afferent nociceptive signaling, sympathetic activation, and subsequent inflammatory cascade activation. While previous studies have evaluated the impact of regional anesthesia on NLR and PLR, the influence of PENG block on SII in hip arthroplasty has not been previously investigated.
The primary objective of this study is to determine whether PENG block reduces postoperative SII levels compared with sham block in elderly patients undergoing total hip arthroplasty under spinal anesthesia.
Peripheral venous blood samples will be collected preoperatively and at predefined postoperative time points (e.g., 12, 24, and 48 hours). The primary endpoint will be postoperative SII at 24 hours or the change from baseline (ΔSII), depending on statistical analysis plan.
This study aims to determine whether motor-sparing regional anesthesia may modulate systemic inflammatory response beyond analgesic effects, potentially contributing to improved perioperative outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ASA classification I-III
- •Aged 65-100 years
- •Who will be scheduled for hip arthroplasty under spinal anesthesia
排除标准
- •Patients who have a history of bleeding diathesis
- •Take anticoagulant therapy
- •History of chronic pain before surgery
- •Multiple trauma
- •patients unable to assess their pain (dementia)
- •patients operated under general anesthesia
- •patients having an infection in the region of the procedure
- •the patient who does not accept the procedure
研究组 & 干预措施
Sham blocks
PENG block with 20ml of 0.9% sodium chloride
干预措施: sodium Chloride (Drug)
PENG block
PENG block with 20ml 0f 0.2% ropivacaine
干预措施: Ropivacaine 0.2% Injectable Solution (Drug)
结局指标
主要结局
Systemic Inflammation Response Index (SIRI)
时间窗: 12 hours after surgery
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.
次要结局
- Systemic Inflammation Response Index (SIRI)(24 hours after surgery)
- Systemic Inflammation Response Index (SIRI)(48 hours after surgery)
- Aggregate Index of Systemic Inflammation (AISI)(12 hours after surgery)
- Aggregate Index of Systemic Inflammation (AISI)(24 hours after surgery)
- Aggregate Index of Systemic Inflammation (AISI)(48 hours after surgery)
- Platelet Mass Index (PMI)(12 hours after surgery)
- Platelet Mass Index (PMI)(24 hours after surgery)
- Platelet Mass Index (PMI)(48 hours after surgery)
- C-reactive Protein (CRP) Concentration(12 hours after surgery)
- C-reactive Protein (CRP) Concentration(24 hours after surgery)
- C-reactive Protein (CRP) Concentration(48 hours after surgery)
- Postoperative Pain Intensity (NRS)(4 hours after surgery)
- Postoperative Pain Intensity (NRS)(8 hours after surgery)
- Postoperative Pain Intensity (NRS)(12 hours after surgery)
- Postoperative Pain Intensity (NRS)(24 hours after surgery)
- Postoperative Pain Intensity (NRS)(48 hours after surgery)
- Opioid Consumption(48 hours after surgery)
- Time to First Rescue Analgesia(48 hours after surgery)