Intravenous Lidocaine to Reduce Postoperative Opioid Consumption and Improve Recovery After Posterior Spinal Fusion for Adolescent Idiopathic Scoliosis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Opioid Consumption
研究概览
简要总结
This study addresses the focus areas of Post-Operative Pain Management. We propose a randomized, triple-blind, placebo-controlled trial to investigate the efficacy of a systemic infusion of intravenous lidocaine as a non-opioid method of post-operative pain management following postoperative spinal fusion for adolescent idiopathic scoliosis (AIS). The outcomes assessed will be (1) the effect of intravenous lidocaine on post-operative opioid consumption, both in-hospital and at three-month follow-up, (2) the effect of intravenous lidocaine on the immunophenotype expressed following surgery, and (3) the effect of intravenous lidocaine on recovery from surgery as assessed by the Patient Reported Outcomes Measurement Information System-Computer Adaptive Tests for Pain Interference (PI) and Mobility (M) (PROMIS-CAT). Thus, we propose a study of a non-opioid method of pain control to minimize opioid consumption in-hospital and at three-months postoperatively, with primary outcomes measures that include morphine-equivalent opioid consumption and PROMIS-Mobility to assess recovery. In addition, we will test the ability of systemic lidocaine to attenuate the systemic inflammatory response to major spine surgery. The immunologic response to surgery has been associated with rehabilitation and recovery following total hip arthroplasty and this study will provide data to support further work.
详细描述
a Phase IV, randomized, triple-blind, placebo-controlled trial with two study groups: postoperative standard of care with opioid patient controlled analgesia (PCA) and IV lidocaine infusion versus postoperative standard of care plus normal saline placebo. Block randomization into one of the two groups will be based on a random table generated using an R-program. Group 1 (Study) will receive intravenous lidocaine during and after posterior spinal fusion for AIS. Group 2 (Control) will receive saline placebo during and after surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study Drug
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adolescent idiopathic scoliosis indicated for posterior spinal fusion.
- •Ages between 12 and 18 years of age.
- •Parent/Guardian capable of providing informed consent for study participation
排除标准
- •Age < 12 or > 18 years old.
- •Unable to obtain consent for the surgical intervention or study, or if mental capacity prohibits the ability to provide consent and complete patient-reported outcomes tools.
- •Diagnosis of sepsis or infection
- •Diagnosis of primary or metastatic malignancy.
- •Participation in another clinical trial.
- •Past or current diagnoses of a cardiac arrhythmia or first/second degree heart block.
- •Past or current seizure disorders.
- •Allergy to bupivacaine.
- •Planned anterior approaches for treatment of scoliosis deformity.
- •Limited English proficiency (e.g. unable to obtain informed consent for surgery without a translator)
- •Ward of the State children
研究组 & 干预措施
Study Group
will receive intravenous lidocaine during and after posterior spinal fusion for AIS
干预措施: IV lidocaine (Drug)
Control Group
will receive saline placebo during and after surgery.
干预措施: Placebos (Drug)
结局指标
主要结局
Opioid Consumption
时间窗: up to 6 weeks after surgery
measured in morphine-equivalent dosage (MED)
次要结局
未报告次要终点