Evaluation of the Effectiveness of tDCS in the Management of Perioperative Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Average Pain at Worst
研究概览
简要总结
The purpose of this study is to determine whether a new medical technology can help reduce post-operative pain. The new technology is called Transcranial Direct Current Stimulation.
详细描述
This study aims to evaluate the effectiveness of transcranial direct current stimulation (tDCS) in the management of postoperative pain. Specifically, this study will determine whether patients undergoing any type of inpatient surgical procedure that routinely requires at least a 1-day inpatient stay post-operatively will report less pain and use less opioid analgesics following a series of 20-minute sessions of tDCS (compared to sham tDCS) delivered up to twice per day post-operatively. In addition to comparing the effects of real tDCS to sham tDCS, the present study will evaluate the interaction of dose (number and frequency of tDCS sessions) and surgery type.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years-75 years of age
- •surgery at Medical University of South Carolina
- •at least 2 days of post-operative stay
排除标准
- •history of seizures or epilepsy
- •family history of seizures
- •taking any medications shown to lower seizure threshold
- •metal implants above the waist
- •brain tumors or lesions
- •pacemaker
研究组 & 干预措施
Real tDCS:Active Comparator
For Real tDCS, stimulation will be delivered in 20-minute-sessions using 2mA current. The anode will be placed over left BA9 or the motor cortex corresponding with the painful area (if applicable). The cathode will be placed over right BA43 (for GI pain) or right BA9 (located via the international 10-20 EEG system).
干预措施: tDCS (Device)
Sham tDCS: Sham Comparator
For sham tDCS, the device will be turned on for 30 seconds and then turned off for the duration of the 20-minute session.
干预措施: tDCS (Device)
结局指标
主要结局
Average Pain at Worst
时间窗: Baseline Only
To assess each participant's average pain at it's worst in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's worst in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Patient Controlled Analgesia (PCA) Hydromorphone Usage
时间窗: Participants were followed for the duration of hospital stay, an average of 48 hours.
The PCA pump usage was downloaded from the PCA pump after discharge from the hospital.
Average Pain at Least
时间窗: Baseline and Discharge
To assess each participant's average pain at it's least in the past 24 hours, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their average pain at it's least in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
Average Pain
时间窗: Baseline Only
To assess each participant's pain on average in the past 24 hours at Baseline, The Brief Pain Inventory (BPI)-short form will be administered. The BPI rapidly assesses the severity of pain and its impact on functioning and has been widely used in both research and clinical settings. Participants rate their pain on average in the past 24 hours using a 0-10 numerical rating scale, where 0=no pain and 10=extreme pain.
次要结局
未报告次要终点