Evaluation of the Effect of the Erector Spinae Plane (ESP) Block on Chronic Postoperative Pain After Lumbar Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To evaluate the effect of ESP block on the BPI score at 3 months postoperatively in patients undergoing lumbar spine surgery.
研究概览
简要总结
The aim of this study is to evaluate whether the erector spinae plane (ESP) block reduces acute and chronic postoperative pain in patients undergoing spinal surgery.
Participants will be assigned to study groups according to the study protocol. Postoperative pain will be evaluated using standardized pain assessment tools. Acute postoperative pain will be assessed using the Numeric Rating Scale (NRS), while chronic pain and its impact on daily life will be evaluated using the Brief Pain Inventory (BPI). Neuropathic pain symptoms will also be assessed using the Self-Administered Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS).
The study aims to determine whether the use of ESP block as part of perioperative pain management can improve postoperative pain outcomes following spinal surgery.
详细描述
Acute postoperative pain is common following spinal surgery, and in some patients, pain may persist beyond the expected recovery period and develop into chronic postoperative pain. Inadequate perioperative pain control may contribute to the development of persistent postoperative pain. Therefore, it is important to evaluate the effects of regional anesthesia techniques used as part of multimodal analgesia not only on early postoperative pain but also on long-term pain outcomes.
The erector spinae plane (ESP) block is an ultrasound-guided regional anesthesia technique that can be used to provide perioperative analgesia in patients undergoing spinal surgery. This study will investigate the effect of ESP block on acute postoperative pain and, particularly, on the development and severity of chronic postoperative pain following spinal surgery.
Postoperative pain intensity will be assessed during the early postoperative period, and participants will subsequently be followed for long-term pain outcomes. Chronic pain severity, its impact on daily activities, and neuropathic pain characteristics will be evaluated using standardized and validated assessment tools.
Data will be compared between patients who receive ESP block and those who do not receive the block to determine the potential effect of ESP block on long-term pain outcomes following spinal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing elective lumbar spinal surgery
- •Aged 18-75 years
排除标准
- •Refusal to participate at the time of enrollment Request to withdraw from the study Inability to provide informed consent Emergency surgery Bleeding diathesis Presence of contraindications to the local anesthetic agents used in the study Chronic opioid use Psychiatric disorders Infection at the injection site
研究组 & 干预措施
Control Group
干预措施: S-LANSS (Diagnostic Test)
ESP Block Group
干预措施: NRS SCORE (Diagnostic Test)
ESP Block Group
干预措施: S-LANSS (Diagnostic Test)
ESP Block Group
干预措施: Total tramadol consumption (Diagnostic Test)
ESP Block Group
干预措施: Post Operative Pain Relievers (Drug)
Control Group
干预措施: NRS SCORE (Diagnostic Test)
Control Group
干预措施: Total tramadol consumption (Diagnostic Test)
Control Group
干预措施: Post Operative Pain Relievers (Drug)
Control Group
干预措施: BPI (Diagnostic Test)
ESP Block Group
干预措施: BPI (Diagnostic Test)
结局指标
主要结局
To evaluate the effect of ESP block on the BPI score at 3 months postoperatively in patients undergoing lumbar spine surgery.
时间窗: 3 months after surgery
Chronic postoperative pain severity and its impact on daily functioning will be assessed at 3 months after surgery using the Brief Pain Inventory (BPI). BPI scores will be compared between the ESP block group and the control group to evaluate the effect of ESP block on chronic postoperative pain.
次要结局
- Postoperative NRS Score and Neuropathic Pain Assessed by S-LANSS(12.hours after surgery for NRS; 3 months after surgery for S-LANSS)
研究者
SINEM SARI
PROF DR
Aydin Adnan Menderes University