A Randomised, Double - Blind, Placebo Controlled Clinical Trial to Assess the Efficacy of the Homeopathic Medication TRAUMEEL S in Controlling Pain After Total Knee and Total Hip Arthroplasty.
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 224
- 试验地点
- 2
- 主要终点
- Cumulative 48-hour postoperative morphine consumption as consumed by the patient via the PCA device
研究概览
简要总结
We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption following Total Knee or Hip Arthroplasty.
224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the trial. Patients will be randomized to receive either intraoperative injection and post operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable oral placebo tablets. Baseline measurements of relevant outcome measures will taken preoperatively.
In the recovery room, the patient will begin to receive IV Dipyrone (Optalgin) 1000mg, for a total of 4 doses during the first 24 hours postoperatively (1000 mg every 6 hours). Once back in the ward, the patient will be connected to an IV Patient-Controlled Analgesia (PCA) device, enabling the self-administration of morphine at a set dose of 1mg every 8 minutes, should the patient require it. The PCA memory registers the time and dose, and the data will be used later to evaluate post-operative pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients of either sex undergoing unilateral THAP or TKAP.
- •Age over 18 years.
- •Signature upon informed consent form
排除标准
- •Participation in another clinical trial within 4 weeks prior to enrollment.
- •Refused to give verbal consent to the telephone interviews
- •Impossibility to be reached during the 14-17 days post operative
- •Inability to comply with the study protocol for any other reason
- •Previous major surgical procedure on ipsilateral leg.
- •Current use of analgesics for any other reason.
- •A history of chronic pain syndrome.
- •Abused legal or illicit drug use.
- •Hypersensitivity to botanicals of the Compositae family
- •Known sensitivity to paracetamol, codeine or tramadol.
研究组 & 干预措施
1
TraumeelS
干预措施: Traumeel S (Other)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Cumulative 48-hour postoperative morphine consumption as consumed by the patient via the PCA device
时间窗: 48h
次要结局
- AUC of NRS scores for days 14-17.(14-17d)
- Cumulative 24-hour postoperative morphine consumption as consumed by the patient via the PCA device(24h)
- Number of primary oral analgesic tablets ingested between days 14-17(14-17d)
- ESR and hs-CPR at three and six days and six weeks(6d and 3weeks)
- IL-6 at three and six days(3 and 6d)
- Post operative blood loss(postoperative period)
- WOMAC(6 weeks)
- Safety of post operative treatment(6 weeks)
- Development of acute confusional state in the postoperative period(14-17d)