Postoperative Pain and Analgesic Use Following Lumbar Discectomy: A Comparative Study of Endoscopic Surgery and Open Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- To compare, under real-world clinical conditions, changes in the intensity of short-term low back pain following lumbar discectomy, based on the surgical technique used: endoscopic versus open surgery
研究概览
简要总结
The lifetime prevalence of lumbosacral radiculopathy is 3 to 5 percent. The most common cause is a lumbar disc herniation. In 10 to 20 percent of patients, medical treatment is insufficient, and surgery is recommended. Lumbar discectomy is the standard surgical treatment. In recent years, minimally invasive techniques-and endoscopic approaches in particular-have become widely adopted.
The main advantage of these techniques lies in their reduced invasiveness, which allows for the preservation of muscle and ligament structures, with less extensive detachment and cutting. This preservation is likely to enable faster rehabilitation during the first few weeks and months after surgery, as well as a shorter hospital stay.
However, the available data focus primarily on medium- and long-term outcomes, and few studies have specifically examined early postoperative pain. Yet this immediate period is a critical factor, particularly regarding patient comfort, analgesic use, and length of hospital stay; it is a major determinant of the quality of immediate recovery. There is very little robust comparative data from real-world clinical settings evaluating the impact of surgical technique on early postoperative pain following lumbar discectomy.
In this context, this study aims to compare changes in short-term low back pain intensity following lumbar discectomy, depending on the technique used (endoscopic versus conventional open surgery), under real-world clinical conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have had radicular and/or lower back pain for more than 6 weeks despite proper medical treatment, leading to the decision to schedule surgery
- •Have symptoms consistent with an MRI showing a herniated disc
排除标准
- •History of lumbar surgery
- •Complex Regional Pain Syndrome (CRPS) type 1 or 2
- •Multiple affected levels
- •Cauda equina syndrome
- •Unscheduled surgery
- •Spondylolisthesis
- •Significantly narrowed lumbar canal (Schizas C or D)
- •Pregnant, laboring, or breastfeeding women
- •Severe psychiatric disorder
- •Unwilling subject who cannot give consent or cannot return for scheduled visits as per the protocol
- •Person under legal protection (guardianship, conservatorship, or judicial safeguard)
- •Person deprived of liberty by judicial or administrative order
- •Person not covered by social security
研究组 & 干预措施
Endoscopis surgery
The procedure is performed under general anesthesia, with the patient in the knee-chest position. After identifying the surgical site using a surgical fluoroscope, sterile skin preparation is performed (by swabbing the area and applying sterile drapes). The approach is percutaneous and transmuscular, using one channel for instruments and another for the endoscopic camera. After exposing the spinal canal, the nerve root is identified and protected. The herniated disc is then accessed following an incision in the posterior longitudinal ligament and resected using a disc forceps. The procedure concludes with skin closure.
干预措施: Endoscopic surgery (Procedure)
Open surgery
The procedure is performed under general anesthesia, with the patient in the knee-chest position. After identifying the surgical level using a surgical fluoroscope, sterile skin preparation is performed (by swabbing the area and applying sterile drapes). A skin incision is made to allow for a posterior approach with muscle dissection. Recalibration is performed to expose the nerve structures. The nerve root is identified and protected; the herniated disc is then accessed after incision of the posterior longitudinal ligament and resected using a disc forceps. Closure is performed layer by layer (fascia, subcutaneous tissue, skin).
干预措施: Open surgery (Procedure)
结局指标
主要结局
To compare, under real-world clinical conditions, changes in the intensity of short-term low back pain following lumbar discectomy, based on the surgical technique used: endoscopic versus open surgery
时间窗: day 3
Change in lumbar Visual Analog Scale (VAS) between preoperative and Day 3. VAS provides a pain intensity score out of 10, 0 representing "no pain" and 10 representing "pain as bad as it could possibly be".
次要结局
未报告次要终点