Postoperative Pain and Analgesic Use Following Lumbar Discectomy: A Comparative Study of Endoscopic Surgery and Open Surgery (DISCOPAIN)
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Jonathan LEBHAR, Dr
- 电话号码：+332 23 25 30 70
- 邮箱：jlebhar@vivalto-sante.com
学习地点
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Saint-Grégoire、法国、35760
- 招聘中
- Centre hospitalier Privé Saint-Grégoire
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接触：
- Marion Mandon, PhD
- 电话号码：+33678277672
- 邮箱：drc@vivalto-sante.com
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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.
|
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.
|
|
其他：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).
|
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).
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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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
大体时间：day 3
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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".
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day 3
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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