Erector Spinae Plane Block in Lumbar Release Surgery : Double-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Consumption of postoperative morphine within 72 hours of the operation
研究概览
简要总结
The aim of this study is to observe or not a reduction in the consumption of morphine within 72 hours of the realization of an erector spinae plane block when preparing for a non-instrumented spine surgery.
详细描述
Posterior lumbar spine surgery is surgery described by patients as painful. While fusion surgery seems more painful than simple release surgery, release surgery remains a painful surgery for patients. The management of post-operative pain is therefore a priority for anesthesiological-surgical teams.
Multimodal analgesia, already recognized for other surgeries, is one of the keys to success, combining oral analgesics and regional local anesthetics.
The recourse to the realization of a block of the erector muscles of the spine was described for the first time in 2016, it is described there in the literature as not presenting any particular risk, simple to apply and having a satisfactory analgesia action. However, this process is little described in the context of spine surgery and even less in the context of randomized controlled trials.
The investigator therefore hypothesize that the realization of a block of the erector muscles of the spine, because of its satisfactory analgesia action mentioned above, will decrease the consumption of postoperative morphine and at the same time reduce the side effects due to the latter.
On the other hand, no study has evaluated the effectiveness of spinal block as part of an Enhanced Rehabilitation After Surgery (RAAC) program. Indeed, the effectiveness of this practice has already been proven in a context of conventional care, but to date no studies have been carried out in the context of care involving the original elements of the RAAC, such as rapid mobilization and multimodal oral analgesia, which could impact the effectiveness of the erector muscle blocks of the spine.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Patient with medical insurance.
- •Patient twho received information about study and signes a consent to participate in the study.
- •Major patient to be operated on for lumbar release surgery without arthrodesis or osteosynthesis posterior (herniated disc repair, one or two level recalibration, laminectomy) +/- implant interlaminar.
- •Patient with an ASA score of 1, 2 or 3.
排除标准
- •Minor patient.
- •Patient with morphine intolerance
- •Patient with allergy to local anesthetics.
- •Patient consuming morphine for more than 3 months.
- •Pregnant or breastfeeding patient.
- •Patient scheduled for cancer surgery or trauma surgery.
- •Patient participating in another interventional study.
- •Patient with a history of lumbar arthrodesis.
- •Patient requiring lumbar surgery with arthrodesis.
- •Patient refusing to sign the consent form.
- •Patient for whom it is impossible to give informed information.
- •Patient under the protection of justice, under curatorship or under tutorship.
结局指标
主要结局
Consumption of postoperative morphine within 72 hours of the operation
时间窗: 72 hours
次要结局
- Onset of nausea and vomiting within 72 hours of the operation.(72 hours)
- Digital visual scale to assess pain of patient within 72 hours of the operation.(72 hours)
- Walking perimeter measurement by the physiotherapist during the 72 hours following the intervention.(72 hours)
- Onset of complication within 30 days of the operation.(30 days)