A Prospective Study on the Comparison of Postoperative Pain According to the Use of Cocktail Therapy in Laminoplasty
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Change from Baseline in Pain (VAS/Visual Analog Score)
研究概览
简要总结
This study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty
详细描述
This study is the first prospective randomized controlled trial to analyze the effects and safety of multimodal cocktail injections after cervical laminoplasty. Through this study, we anticipate that the potential usefulness of multimodal cocktail analgesic injections in various aspects of spinal surgery will be demonstrated, offering valuable insights and possibilities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with cervical myelopathy or radiculopathy and scheduled to undergo laminoplasty
- •Recorded preoperative upper limb pain (Visual Analog Scale [- VAS] ), neck pain (VAS), Japanese Orthopaedic Association (JOA) scores, and Neck Disability Index (NDI) scores.
- •Adults aged 20 years and above, but below 80 years capable of articulating their own pain or functional abnormalities
- •Cognitive function at a level that enables them to comprehend and adhere to study procedures
排除标准
- •Previous surgical treatment of the cervical spine.
- •Adolescents aged 20 years or below, pregnant individuals, or those with the potential for pregnancy.
- •Hypersensitivity reactions to mixed medications used in Cocktail therapy. (morphine 5 mg, ropiva 150 mg, tamceton 40 mg, epinephrine 1 mg, ketocin 60 mg, jetiam 1 g).
- •Patients who lack the capacity for medical consent or are unable to communicate effectively in a medical context.
研究组 & 干预措施
Group 2
The group that received cocktail therapy injection into the deep fascia and muscular layer during wound closure.
干预措施: Cocktail injection (Drug)
结局指标
主要结局
Change from Baseline in Pain (VAS/Visual Analog Score)
时间窗: Baseline and Post operation 7 days
A VAS score, also known as a Visual Analog Scale score, is a common method used in healthcare and research to measure subjective or self-reported sensations or experiences, such as pain, anxiety, mood, or other subjective states. It typically consists of a horizontal or vertical line, usually 10 centimeters in length, with anchor points at either end. One end is labeled with the most negative or extreme aspect of the sensation or experience being measured, and the other end is labeled with the most positive or least extreme aspect.
Change from Baseline in function (JOA/Japanese Orthopaedic Association Score) score
时间窗: Baseline and Post operation 7 days
The JOA score is often calculated based on a specific set of criteria and is used to help guide treatment decisions and monitor a patient's progress. It provides a standardized way to assess and communicate the clinical status of individuals with cervical myelopathy. The score may range from 0 (severe impairment) to 17 (normal function), with lower scores indicating greater disability.
Change from Baseline in function (NDI/Neck Disability Index score) score
时间窗: Baseline and Post operation 7 days
The NDI questionnaire typically consists of ten questions or items, and individuals are asked to rate their level of disability or limitation in various aspects of daily life due to neck pain. The questions cover a range of activities, including personal care, work, sleep, and recreational activities. Each question is scored on a scale from 0 to 5, with 0 indicating no disability and 5 indicating severe disability. The individual's responses to these questions are then totaled to calculate the NDI score, usually expressed as a percentage.
次要结局
未报告次要终点
研究者
Kyung-Chung Kang
Associate Professor, Spine Center, Department of Orthopaedic Surgery
Kyunghee University Medical Center