Magnesium as an Adjunct for Pain Treatment After Surgery for Thumb Base Arthrosis, a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Pain after 48 hours from surgery
研究概览
简要总结
A randomised controlled trial of addition to the standard pain treatment of 1000 mg oral magnesium citrate or placebo for 7 Days during surgery for thumb base arthrosis. Intraoperative nociception will be measured with the NoL-index with a PM-200 machine.
详细描述
Our hypothesis is that an addition of oral 1000 mg magnesium citrate daily for 7 Days starting at the day of the surgery will decrease the postoperative pain and improve the recovery after surgery. It will be given as an supplement to the regular pain treatment with acetaminophen and oxycodone that are used in our hospital and compared to a placebo. The choice of treatment will be blinded for the patient, the care providers and for the research team doing the evaluation.
The pain level will be collected Before surgery, postoperatively and at 14 Days after surgery and by a self reporting form during the first 7 Days. The patients will also report their recovery with a modified QoR-15 form. QoR-15 is validated in a Swedish version.
Magnesium is shown to reduce postoperative pain in some studies that used iv magnesium sulphate. For long lasting pain conditions oral magnesium is shown to improve the patients well being and decrease their pain in some conditions. Magnesium acts as a mild antagonist at the NMDA-receptor. Thus low levels of magnesium is thought to increase the risk of long lasting postoperative pain. Therefore there are reason to expect a higher dose of magnesium supplement decreases the long lasting post operative pain.
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
Closed envelope randomisation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Planned for surgery of thumb base arthrosis with trapeziectomy with ligament reconstruction tendon interposition.
- •Age 18 years or older.
- •low anesthetic risk, ASA class 1 or
- •Be able to take oral medication.
- •Be able to read and communicate in Swedish.
排除标准
- •Age under 18 years.
- •Heartfailure, kidney failure, ischemic hearth disease.
- •Previous neuropathic pain or complex pain syndrome.
- •Serious psychiatric morbidity
- •Not able to communicate in Swedish
- •Skin problems that makes the application of NoL-sensor impossible.
结局指标
主要结局
Pain after 48 hours from surgery
时间窗: Self reported at 48 hours after surgery.
Pain measured with a self reported written numerical rating scale with eleven steps 0-10 where 0 is no pain and 11 is the worst pain possible (NRS) after 48 h after surgery.
次要结局
- Pain 1 hour after surgery(1 hour after leaving the operating theatre)
- QoR15swe (Quality of Recovery, a 15 item questionaire translated to swedish)(Day 1 to day 7 after surgery.)