Comparative Efficacy of Ultrasound-guided Erector Spinae Plane Block Versus Wound Infiltration for Postoperative Analgesia in Instrumented Lumbar Spinal Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Postoperative pain intensity
研究概览
简要总结
This study aimed to compare the efficacy of ultrasound-guided erector spinae plane block (ESPB) with that of wound infiltration (WI) for postoperative analgesia in lumbar spinal surgeries involving instrumentation.
详细描述
In this randomized controlled trial, 80 patients were divided into two groups: ESPB (n=40) and WI (n=40). Postoperative pain intensity was assessed using the Visual Analog Scale (VAS) at multiple time points within 24 hours. Additionally, opioid consumption, time to first rescue analgesia, incidence of postoperative nausea and vomiting (PONV), and patient satisfaction were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Randomization and Blinding A computer-generated random number sequence was used for randomization. Allocation was concealed via sealed, opaque envelopes, which were opened just before the intervention. Both the patients and the outcome assessors were blinded to the group assignments. The anesthesiologist who administered the block was aware of the group allocation but did not participate in the postoperative assessments.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Elective lumbar spine surgery involving instrumentation
- •ASA physical status I-III
- •Ability to provide informed consent
排除标准
- •Known allergies to local anesthetics
- •Coagulopathy or anticoagulant therapy
- •Infection at the injection site
- •Preexisting neurological disorders affecting sensory perception
- •Pregnancy
- •Inability to understand the visual analog scale (VAS) for pain assessment
结局指标
主要结局
Postoperative pain intensity
时间窗: 1., 6., 12., 24., and 48. hours postoperatively
The pain intensity was assessed via the visual analog scale (VAS).The VAS is a 10 cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
次要结局
- Time to first request for rescue analgesia(Noted in hours in the first 48 hours postoperatively)
- Total Opioid Consumption(In the first 48 hours postoperatively)
- Incidence of Side Effects(Recorded as binary outcomes (present/absent) in the first 48 hours postoperatively)
- Patient Satisfaction with Pain Management(At 48 hours postoperatively)
研究者
YÜCEL YÜCE
Associate Professor
Saglik Bilimleri Universitesi