Effect of Anaesthetic Techniques on Clinical Outcome After Lumbar Spine Surgery: Regional Versus General Anaesthesia. A Prospective 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
- Morphine consumption
研究概览
简要总结
Background: Lumbar spine surgery can be performed using different anaesthetic techniques such as general endotracheal anaesthesia (GA) or spinal-based regional anaesthesia (RA), that have different side effect profiles (e.g. opioids - nausea, vomiting, pruritus, sedation; local anaesthetics - motor weakness) which may affect quality of recovery in different ways.
Aim of the study: The purpose of this study is to determine the effects of GA and RA in lumbar spine surgery on clinical outcome, combining validated patient-reporting instruments and morbidity such as serious adverse events.
Hypothesis: The investigators hypothesize that in patients undergoing lumbar spine surgery, RA shows significant advantages as compared to GA with respect to the postoperative pain score, the degree of postoperative nausea and vomiting (PONV), the postoperative anaesthetic care unit (PACU) and anaesthesia time and the satisfaction of patients and surgeons.
Design of the study: This is a single-centre two-arm randomised-controlled trail.
详细描述
- Background Lumbar spine surgery can be performed using different anaesthetic techniques such as general endotracheal anaesthesia (GA) or spinal-based regional anaesthesia (RA). In a recent review several studies showed a decreased postoperative pain score in the RA groups (1). But only few randomized control trials (RCT) have been performed comparing these two anaesthetic techniques and have shown partly conflicting results (2-5).
Each anaesthetic agent or regimen has a particular side effect profile (e.g. opioids - nausea, vomiting, pruritus, sedation; local anaesthetics - motor weakness) which may affect quality of recovery in different ways. Although there are few data examining the correlation between side effects from different analgesic regimens and quality of recovery per se, some data suggest different analgesic regimens will result in different side effects and consequently different levels of quality of recovery.
Although inconsistent data exist covering surgery time, anaesthesia time, postoperative anaesthetic care unit (PACU) time and postoperative analgesic dose requirements (6-8).
But there are some hinds that RA leads to better results concerning postoperative mortality and morbidity in opposite to general anaesthesia (9-10). Also RA showed better results concerning economic aspects (11,12).
No clinical trials have sufficient subject numbers to determine definitively the effects of anaesthetic techniques on minor or major benefits concerning clinical outcome. There is insufficient evidence to confirm or deny the ability of these two anaesthetic techniques to affect major postoperative mortality or morbidity and there is currently no sufficient evidence that RA or GA have any clinically significant beneficial effect on postoperative outcome. Further there are still insufficient data to determine if the type of anaesthetic technique, degree of analgesia and the presence of side effects may influence quality of life, quality of recovery, patient and surgeon's satisfaction and length of hospitalisation.
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
- Single (Outcomes Assessor)
盲法说明
Outcomes Assessor and statistician are blinded.
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 must give informed consent before registration.
- •Age ≥ 18 years
- •Physical Status Classification of the American Society of Anaesthesiologists Score (ASA) ≤ 3
- •Patient with a diagnosed lumbar spinal stenosis or a herniated lumbar disc for elective neurosurgery
排除标准
- •Infection at the site of the operation field
- •Longterm History (≥ 6 month) of neuropathic pain on the operation site
- •Revision surgery and/or follow-up operations
- •Severe coagulopathy (platelet count < 100.000 / mL3 or Thromboplastin time < 50%)
- •Allergy to local anaesthetics or opioids
- •Previous drug dependency or chronic use of opioids (≥ 6 month)
- •Psychiatric disorder precluding understanding of information on trial related topics or given informant consent
研究组 & 干预措施
General Anaesthesia
General Anaesthesia during surgery
干预措施: General anaesthesia (Procedure)
Regional Anaesthesia
Regional Anaesthesia during surgery
干预措施: Regional anaesthesia (Procedure)
结局指标
主要结局
Morphine consumption
时间窗: From immediately after the operation until 48 hours postoperative
Cumulated morphine consumption in mg
次要结局
- Anesthesia time(Day of surgery)
- VAS score(Postoperative at the day of surgery until 48 hours postoperative)