Evaluating General Anesthesia With Erector Spinae Plane Block vs. Spinal Anesthesia With Erector Spinae Plane Block in Lumbar Decompression Surgeries
试验速览
- 阶段
- 3 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- QoR15 survey scores
研究概览
简要总结
The purpose of this study is to determine the optimal anesthetic routine for lumbar decompression surgery. General Anesthesia is the standard of care in spine surgery. Spinal anesthesia in decompressive procedures can be the new standard of care. Recently, it has been found that regional analgesia is option that has been shown to improve pain and opioid-related outcomes after spine surgery, but has not yet been studied in combination with spinal anesthesia. This is study that consists of two groups: standard of care general anesthesia with a nerve block and a spinal anesthesia with nerve block. Patients are randomized to either of the two groups. There will be 71 patients enrolled in each group for this study.
详细描述
An early comparative analysis between GA and SA in spine surgery explored perioperative effects of the technique on cost and satisfaction among patients, anesthesiologists, and surgeons. Patients who underwent surgery under SA had better outcomes, including hemodynamic stability, shorter hospitalization time, and shorter time to return to work. Postoperatively, SA was associated with lower numeric pain rating scale (NPRS) scores and earlier time to mobilization and first oral intake. Moreover, SA had lower costs and higher reported satisfaction among patients, surgeons, and anesthesiologists.
Subsequent studies have consistently concluded that SA is associated with shorter surgical duration and less blood loss in patients compared to GA for spine surgery. Additionally, hospital length of stay has been reported to be shorter after SA, perhaps due to lower incidence of complications found in several series.
Early postoperative pain control may also be superior after SA in patients undergoing microdiscectomy, attributed to residual sensory block after SA. In addition to higher peaks in pain scores and significantly greater analgesic requirements among the GA group, more episodes of nausea were described, and more antiemetic medications were given.
Intraoperative neurophysiological monitoring (IONM) during procedures such as one and two-level microdiscectomies and laminotomies, use somatosensory evoked potentials (SSEPs), motor evoked potentials (MEPs), and electromyograms (EMGs) as routine during surgery. Surgeons can monitor spinal cord and nerve root function in real-time, take measures to prevent/lessen irritation or potential damage and can detect intraoperative neurologic injuries. Microdiscectomies and laminotomies are one of the most common spinal procedures, which can be performed in both its "open" and "minimally invasive" variations, is a well-established, safe procedure. However, studies have shown that the use of IONM in smaller, less complicated procedures such as microdiscectomies or laminotomies, may add to the overall cost without providing many benefits. Decompressive surgeries under SA cover only the spine and nerve roots within a specific region. Subsequently, SA does not transmit sensory impulses to the brain, therefore, neuromonitoring such as somatosensory evoked potentials (SSEPs) are not required in cases such as these. Certain types of IOMN can be performed under GA, as transmissions of sensory impulses are sent to the brain to identify neural irritation or injury and define the nature of the injury, which will allow the surgeon to complete the procedure without risking further injury.
Despite broad patient acceptance of SA for lower extremity procedures, and abundant evidence to support superior outcomes after orthopedic surgery, SA has never gained wide acceptance in lumbar spine surgery. Arguments against SA for lumbar decompression surgeries include the potential for airway complications in sedated prone positioned patients, the possibility for neural injury if an awake patient moves during decompressive procedures, the potential for intraoperative conversion to GA due to insufficient duration or failed SA, and confounding of the early postoperative neurologic examination.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients from the ages 18- 80 years
- •Patients with one or two-level microdiscectomy, laminotomy, or foraminotomy - prior spine surgery is allowed only if surgery was preformed at other levels.
- •Able to follow study protocol
- •Able to provide informed consent
排除标准
- •Surgery with planned need for postoperative surgical drain.
- •Allergies of contraindication to any study anesthetic or analgesic medications.
- •Morbid obesity, defined as BMI > 35 kg/m
- •Involved in the study of another investigational product that may affect the outcome.
研究组 & 干预措施
GA + ESP Block
General anesthesia: induction of general anesthesia to facilitate endotracheal intubation: fentanyl (up to 2μg.kg.min-1), propofol (1-2 mg.kg-1), vecuronium (1-2 mg.kg-1).
干预措施: General anesthetic (Drug)
SA + ESP Block
Spinal Anesthesia: Patients will be provided with iv sedation, if desired, to facilitate placement of spinal anesthetic. Midazolam (2-5mg, iv), ketamine (up to 20 mg, lv) and/or propofol (0.1-0.2 mg/kg) will be permitted.
干预措施: SA + ESP (Drug)
结局指标
主要结局
QoR15 survey scores
时间窗: The QoR15 survey will be assessed preoperatively (in holding area). It will be assessed again immediately after surgery in the PACU and then at 2-weeks postoperatively at the patient's first follow-up visits
The primary outcome is the difference in the quality of recovery-15 (QoR15) score between the groups at each timepoint (before surgery, after surgery, and at their first 2 week follow-up visit). For this survey, a high number represents something that occurs often, while a low number indicates something that rarely or never occurs. Depending on the category/question asked, this may be good or bad. The questions on the survey will be split and compared so that for one subset of questions a high number is good while the opposite is true for the other subset of questions. This will be done so the comparison between groups is more accurate and meaningful.
次要结局
- NRS Survey Pain Scores(The NRS will be assessed preoperatively (in holding area), postoperatively in PACU, and 2 weeks postoperatively at the patient's first follow-up)
- Opioid Consumption(From surgery through 24 hours postoperatively)
- Anesthetic(s) Time(Intraoperatively)
- Surgical Duration(Intraoperatively)
- Complications(Length of stay at the hospital (up to 3 days postoperatively))
