The Relationship Between the Preoperative Neutrophil-to-lymphocyte Ratio (NLR) and Postoperative Nausea and Vomiting (PONV) in Lumbar Spine Surgery Patients, as Well as the Impact of Erector Spinae Plane Block on NLR and PONV
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 主要终点
- Record the neutrophil count and lymphocyte count on the first day after surgery and calculate the neutrophil-to-lymphocyte ratio (NLR)
研究概览
简要总结
This study aims to investigate whether preoperative NLR (Neutrophil-to-Lymphocyte Ratio) serves as a biomarker for PONV (Postoperative Nausea and Vomiting). It also examines the impact of erector spinae plane block on NLR and PONV. Furthermore, the research explores the effect of erector spinae plane block on postoperative pain relief in spinal surgery and its influence on the usage of opioid medications.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective posterior lumbar spine surgery in a prone position under general anesthesia.
- •ASA classification grades I to II.
- •Age between 18 and 80 years old.
- •Signed the informed consent for this study.
排除标准
- •Preoperative blood transfusion.
- •Uncontrolled systemic diseases.
- •Patients with known uncontrolled systemic inflammatory diseases (e.g., rheumatoid arthritis, lupus, or active infections).
- •Gastrointestinal system disorders.
- •History of antiemetic and anticholinergic drug use.
- •History of adverse reactions related to surgery, deformity correction surgeries, defined as procedures involving instrumentation across three or more levels or aimed at correcting scoliosis or kyphosis.
- •Severe spinal deformities.
- •Infection at the puncture site.
- •Coagulation disorders.
- •Long-term use of sedatives and analgesic drugs before surgery.
- •Patients with mental illness or communication barriers.
- •Allergic to ropivacaine.
- •Participants involved in other clinical studies within the past 3 months.
- •History of previous lumbar surgeries.
- •Subjective unwillingness to participate in this study.
结局指标
主要结局
Record the neutrophil count and lymphocyte count on the first day after surgery and calculate the neutrophil-to-lymphocyte ratio (NLR)
时间窗: Within the first 24 hours.
The neutrophil count and lymphocyte count and calculate the neutrophil-to-lymphocyte ratio (NLR).
Record nausea and vomiting within the PACU and during the first 24 hours and second 24 hours after surgery.
时间窗: Within the first 24 hours and the second 24 hours after surgery.
Patients with a nausea and vomiting score of 1 point or above (0 points = no nausea, 1 point = nausea, 2 points = dry heaving, 3 points = vomiting) are treated with ondansetron as an antiemetic.
Record the need for antiemetic medication within the PACU and during the first 24 hours and the second 24 hours postoperatively.
时间窗: Within the first 24 hours and the second 24 hours after surgery.
Record the need for antiemetic medication within the PACU and during the first 24 hours and the second 24 hours postoperatively.
次要结局
- Record the postoperative awakening time.(Within 24 hours.)
- Document the occurrence rate of opioid-related side effects such as dizziness and urinary retention.(Within 1 week)
- Overall VAS (Visual Analog Scale) pain scores at 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours postoperatively during rest and movement.(At 2 hours, 6 hours, 12 hours, 24 hours, and 48 hours after surgery)
- Record the satisfaction scores for pain management at 24 and 48 hours.(Within the first 24 hours and the second 24 hours after surgery)
- Postoperative stay in the PACU (Post-Anesthesia Care Unit).(Within 24 hours.)
- Record the time of the initial press of the patient-controlled analgesia pump.(Within the first 24 hours and the second 24 hours after surgery)
- Time of discharge post-surgery.(Within 2 weeks.)
- Measure neutrophil extracellular trap (NETs) formation in serum on the first postoperative day.(At 24 hours after surgery)
- Record the time of the patient's initial self-administration of the pain pump during the first 24 hours and the second 24 hours after surgery.(Within the first 24 hours and the second 24 hours after surgery)
- Record the extubation time after surgery.(Within 24 hours.)
研究者
Guanghan Wu
Attending physician
Qianfoshan Hospital