EVALUATION OF POSTOPERATIVE EFFECT OF THREE DIFFERENT ANALGESIC TECHNIQUES IN PATIENTS UNDERGOING LUMBAR FIXATION SURGERY USING SALIVARY OPIORPHIN LEVEL: A PROSPECTIVE RANDOMIZED CLINICAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Comparison of the Postoperative Efficacy of Analgesic Methods Using Salivary Opiorphin Levels
研究概览
简要总结
Lumbar spinal stenosis is a degenerative condition characterized by the narrowing of the space surrounding the neurovascular structures of the lumbar vertebrae, resulting from age-related changes in the intervertebral discs, ligamentum flavum, and facet joints. It commonly causes unilateral pain in the lower back, hips, and legs, often described as cramping or burning. Postoperative pain management in these cases frequently involves oral opioids or intravenous administration using patient-controlled analgesia devices. However, opioids are associated with side effects such as reduced gastrointestinal motility, urinary retention, and respiratory depression.
To mitigate these issues, local anesthetic wound infiltration is widely employed by surgeons to manage postoperative pain and reduce opioid consumption following lumbar spinal surgeries.
The primary aim of this study is to compare the postoperative efficacy of three different analgesic methods in patients undergoing elective lumbar fixation surgery, using the percentage change in salivary opiorphin levels as a marker. Additionally, the study seeks to evaluate the correlation between these changes and postoperative pain scores, as well as the amount of opioids consumed.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled to undergo lumbar fixation surgery under general anesthesia
- •aged between 18 and 65 years,
- •American Society of Anesthesiologists physical status classification of I-II
排除标准
- •Patients with a known allergy to local anesthetics.
- •Patients who used opioid analgesics within 48 hours prior to sample collection.
- •Patients with a history of smoking or alcohol consumption.
- •Patients with conditions affecting salivary flow, such as xerostomia or those who have undergone radiotherapy.
- •Patients with infectious diseases known to be transmissible through saliva.
- •Patients with an ASA physical status classification of III or higher.
- •Patients unable to use a patient-controlled analgesia (PCA) device.
- •Patients who do not consent to the study procedures.
研究组 & 干预措施
Group Local Infiltration
干预措施: infiltration (Other)
Group Control
Group Erector Spinae Plane Block
干预措施: Erector Spinae Plane Block (Other)
结局指标
主要结局
Comparison of the Postoperative Efficacy of Analgesic Methods Using Salivary Opiorphin Levels
时间窗: postoperative 24 hours
The primary aim of this study is to compare the postoperative efficacy of three different analgesic methods applied to patients undergoing elective lumbar fixation surgery by assessing the percentage change in salivary opiorphin levels. Additionally, the study aims to evaluate the correlation of these changes with postoperative Visual Analog Scale (VAS) pain scores and the amount of opioids consumed.
次要结局
- Total amount of opioid consumption(Postoperative 24 hours)
- Pain scores in first 24 hours at rest and at movement(postoperative 24 hours)
- Correlation between basal Salivary Opiorphin Levels and total 24 hours opioid consumption and pain scores(postoperative 24 hours)