Perioperative Multimodal Analgesia Including Intravenous Lidocaine Infusion for Pain Management Following Idiopathic Scoliosis Correction Surgery in Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Total morphine utilization
研究概览
简要总结
Surgical correction of scoliosis in children is a long procedure, with an equivalently long recovery time, that is commonly performed at BC Children's Hospital. Treating pain immediately after the procedure is a priority for children during recovery. Morphine is one medication that can be used to manage post-operative pain, but unfortunately, its use is accompanied by a number of side effects which can affect recovery. These include nausea, vomiting, pruritus, sedation, dysphoria, respiratory depression, constipation, ileus, and urinary retention.
In order to control pain and reduce morphine consumption, intravenous lidocaine is being investigated. This therapy has been beneficial in adult populations undergoing abdominal surgery and has been associated with decreased post-operative pain, decrease use of opioids including morphine, and ileus. These all contribute to shorter lengths of stay in the hospital and better recovery in the adult population.
Intravenous lidocaine is used by some anesthesiologists at BC Children's Hospital to manage post-operative pain in children receiving surgical correction for scoliosis, but this is not a standard of practice. We now propose to conduct a double-blind randomized controlled trial to determine if intravenous lidocaine, infused from start of anesthesia up to 48 hours post-operatively, will reduce morphine use and improve post-operative pain in the pediatric population.
详细描述
Objectives:
The primary objective of this study is to determine if perioperative IV lidocaine therapy (P-IVLT) reduces 48-hour post-operative morphine utilization compared with a control, in adolescents undergoing PSIF. Secondary objectives of this study are to determine the effect of P-IVLT on self-reported pain scores, time to documented first stand, time to first walk of greater than 15 steps, and length of hospital stay (LOS).
Research Methods:
This will be a placebo-controlled, double-blind randomized control trial (RCT) comparing 48-hour postoperative morphine utilization among adolescents undergoing PSIF who have been randomly assigned to one of two groups:
Intervention group (A) will receive P-IVLT in addition to the standard multimodal analgesia. P-IVLT will consist of 1 mg/kg bolus at start of anesthesia (T0), followed by 2 mg·kg-1·hr-1 infusion for 8 hours (T1), then continued at 1 mg·kg-1·hr-1 infusion thereafter and postoperatively until T0 + 48 hours (T2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Following receipt of informed consent, participants will be randomized by the Pharmacy Research Support Pharmacist. Pharmacy research staff will prepare an appropriate randomization schedule (patients randomized to P-IVLT or control) and deploy blinded study drug to the operating room, anesthesia care unit, and post-surgical ward as required. Unless emergency unblinding is required, the following people will remain blinded to group allocation until the full cohort has been recruited and data collection has been completed:
- All anesthesia, APS, nursing, clinical pharmacists and surgical staff involved in the patient's clinical care
- The patient and their family
- Research staff involved in recruitment and data collection
入排标准
- 年龄范围
- 10 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-III
- •Diagnosed with Idiopathic scoliosis
- •Undergoing single-stage posterior spinal instrumentation and fusion
排除标准
- •Thorascopic tethering procedure
- •Two-stage procedure
- •Abnormal developmental profile
- •Congenital/neuromuscular scoliosis
- •Requiring PICU admission
- •Known allergy to lidocaine
- •Known cardiac, renal or liver disease or dysfunction
- •Pre-existing pain complaints, i.e. on regular analgesic medications
- •Current psychiatric diagnosis, e.g. anxiety, depression, eating disorder, defined according to DSM criteria.
- •Requiring non-standard post-op pain management
- •Any history of seizures
- •Unplanned staged procedure
- •Weight < 5th centile or > 85th centile for age
- •Porphyria
研究组 & 干预措施
Intravenous lidocaine
1% preservative free lidocaine 10 mg/ml in 0.9% NaCl
干预措施: Lidocaine (Drug)
Intravenous saline control
0.9% sodium chloride, also known as normal saline
干预措施: Saline Solution (Drug)
结局指标
主要结局
Total morphine utilization
时间窗: 48 hours post-operatively
Documented from acute pain service charts (mg/kg)
次要结局
- Mobililzation(through hospital stay, an average of 5 days)
- Urinary incontinence(through hospital stay, an average of 5 days)
- Postoperative pain(from emergence in the anesthetic care unit through 48 hours post-operatively)
- Postoperative pain (II)(through study completion, 48 hours post-operatively)
- Recovery(through hospital stay, an average of 5 days)
- Total morphine utilization(12, 24, 36 hours post-operatively)
研究者
Gillian Lauder
Staff Anesthesiologist
University of British Columbia