Effect of PENG Block on Inflammatory Parameters and Mortality in Geriatric Patients Undergoing Hip Fracture Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- SIRI-systemic inflammatory response index
研究概览
简要总结
In this study, the investigators the effect of PENG block on SIRI (systemic inflammation response index) and 30-day mortality in geriatric patients(over 65 years old) undergoing hip surgery, and the effect on the length of hospital stay.
详细描述
Patients over the age of 65 who were scheduled for surgery due to hip fracture were included in the study. According to the power analysis, it was estimated that at least 52 patients would be required for adequate statistical power. Initially, a total of 60 patients were assessed for eligibility and planned to be divided into two groups by randomization. Multimodal analgesia was applied to both groups.
The first group (Group P) received a preoperative Pericapsular Nerve Group (PENG) block, while the second group (Group C) did not receive an analgesic block and was given paracetamol and tramadol hydrochloride for analgesia. All patients received spinal anesthesia using 10 mg of hyperbaric bupivacaine.
Preoperatively, IL-6, CRP, and complete blood count (CBC) tests were performed on all patients, and these tests were repeated 4, 24, and 48 hours after the surgical stimulus. At the end of the operation, total blood loss, transfused blood products and their volumes, and operation time were recorded. Postoperatively, NRS pain scores, time to first analgesic requirement, length of hospital stay, and 30-day mortality were evaluated.
Post-Completion Study Flow
After completion of the study, a total of 60 patients were assessed for eligibility as planned. Of these, 2 patients declined to participate. The remaining 58 patients were randomized into two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA 1-2-3 score
- •Hip Fracture Surgery
排除标准
- •Refusal to participate in the study
- •ASA score of 4 and above
- •Obesity (BMI >40)
- •Failure of spinal block
- •Switching to general anesthesia
- •Patients undergoing revision surgery
- •Patients with multitrauma
- •Patients with old fractures (>3 weeks)
- •Patients receiving preoperative and intraoperative sedation
- •Patients with active malignancy receiving RT, KT
- •Patients with active infection, patients receiving antibiotic treatment
- •Patients with contraindications for regional anesthesia techniques
- •Patients receiving chronic treatment with steroids or immunosuppressants
- •Patients using anti-inflammatory drugs
研究组 & 干预措施
PENG Block
PENG block will be performed before the surgery. For PENG block, patients are in the supine position is deposited. The convex ultrasound probe is initially placed over the anterior superior iliac spine, then the probe moves medially until the femoral artery is visualized. In this view, iliopectineal eminence (IPE), iliopsoas muscle and tendon, femoral artery and iliac muscle are observed. Between the psoas tendon and the IPE 22 gauge 80 mm block needle is guided and 20cc local anesthetic used in % 0.25 bupivacaine is administered by intermittent aspiration.
干预措施: PENG block (Other)
Control
Standard analgesia method will be applied and analgesia will be provided with tramadol hydrochloride and paracetamol.
干预措施: Control (Other)
结局指标
主要结局
SIRI-systemic inflammatory response index
时间窗: Preoperative, Postsurgery 4. 24. 48.hour
The systemic inflammatory response index (SIRI) is defined as "neutrophil count × monocytes/lymphocyte counts".
IL-6
时间窗: Preoperative, Postsurgery 4. 24. 48.hour
Measurement of IL-6 level in blood
次要结局
- CRP(Preoperative, Postsurgery 4. 24. 48.hour)
- SII(Preoperative, Postsurgery 4. 24. 48.hour)
- NLR(Preoperative, Postsurgery 4. 24. 48.hour)
- NRS score(Postoperative 0-2-8-16-24-36-48 hour)
- Additional analgesic requirement(Postoperative first 24 hour)
- length of hospital stay(1 week)
- Mortality(Postoperative 30 day)
研究者
Burak NALBANT
assistant professor
Ankara City Hospital Bilkent