A Controlled Study to Compare the Effect of Regional Anesthesia by an Erector Spine Plane Block and Intravenous Infusion of Lidocaine on the Rate of Intravenous Morphine Use After Scoliosis Repair Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Morphine consumption
研究概览
简要总结
The goal of the surgical correction of scoliosis is to prevent progression of the curve or progression of restrictive lung disease. After scoliosis surgery, patients experience severe pain. The standard treatment for pain relief after scoliosis surgery is the administration of opiates. However, treatment with these substances involves side effects such as respiratory depression, nausea and vomiting, inhibition of bowel activity and itching. To lower the dose of opiates, different types of painkillers and other techniques can be added.
The purpose of the study is to compare the effect of instillation of lidocaine (which is an analgesic and anti-inflammatory) or regional anesthesia using Erector spinae plane on the dose of morphine consumption, the intensity of pain, the side effects and the quality of recovery during the first 48 hours after surgery to repair scoliosis.
详细描述
The goal of the surgical correction of scoliosis is to prevent progression of the curve or progression of restrictive lung disease. After scoliosis surgery, patients experience severe pain. The standard treatment for pain relief after scoliosis surgery is the administration of opiates. The opiate that is usually used after scoliosis repair surgery to correct scoliosis is morphine. It is given independently by the patients using the patient-controlled analgesia device. However, treatment with these substances involves side effects such as respiratory depression, nausea and vomiting, inhibition of bowel activity and itching. To lower the dose of opiates, different types of painkillers and other techniques can be added.
The purpose of the study is to compare the effect of instillation of lidocaine (which is an analgesic and anti-inflammatory) or regional anesthesia using Erector spinae plane on the dose of morphine consumption, the intensity of pain, the side effects and the quality of recovery during the first 48 hours after surgery to repair scoliosis.
Patients will be randomized to one of 3 groups. The patients do not know which group they belong to.
Group C - control - the patients will receive general anesthesia according to the standard protocol for general anesthesia in this study.
Group B - ESP block - patients will receive general anesthesia according to the standard protocol for general anesthesia in this study. And then the anesthesiologist will perform an ultrasound-guided ESP block
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
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of 12 with normal cognition, who are scheduled to undergo surgery to correct scoliosis and treatment with IV PCA independently for pain relief after surgery; The patients' parents/guardian (in the case of a minor) or the patient himself (in the case of an adult) signed an informed consent form for participation in the study; Patients should be able to operate the PCA device independently
排除标准
- •Patients who do not agree to participate in the study even if their parents signed an informed consent
- •Patients who are unable to operate the PCA device independently
- •Patients under treatment with opioids or cannabis for chronic pain for more than a month;
- •Drug use of any kind;
- •Alcoholism;
- •Patients with depression, anxiety or post-trauma;
- •Moderate-severe insufficiency of one of the systems - respiratory/cardiac/hepatic/renal;
- •Sensitivity to one of the drugs in the research protocol.
研究组 & 干预措施
Erector spinae plane block
Patients will receive general anesthesia according to the standard protocol for general anesthesia in this study. After induction for anesthesia, before the start of the surgery, the anesthesiologist will perform an ultrasound guided ESP block, according to the ultrasound guided erector spinae plane block protocol
干预措施: Lidocaine (Drug)
Lidocaine
Patients will receive general anesthesia according to the standard general anesthesia protocol for this study. In addition, after induction of anesthesia, patients will begin receiving an intravenous infusion of lidocaine at a dose of 0.5 mg per kg per hour, and will continue to receive the infusion after surgery for a total of 24 hours.
干预措施: Lidocaine (Drug)
结局指标
主要结局
Morphine consumption
时间窗: 48 hours after surgery
Dosage of morphine consumption in milligrams that the patients will consume in by pressing on the PCA device in the first 48 hours after surgery to correct scoliosis
次要结局
- Quality of recovery(72 hours after surgery)
- Pain intensity,(48 hours after surgery. The pain will be monitored at 1, 6, 12, 24 and 48 hours after the surgery.)
研究者
Zoya Haitov Ben Zikri
Manager of the anesthesia unit
Assaf-Harofeh Medical Center