NCT03056521Unknown不适用
Effect of Preoperative Information About Pain on Postoperative Pain Experience and Patient Satisfaction in Adult Elective Orthopedic Patients: A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 340
- 试验地点
- 2
- 主要终点
- Post operative pain experience (yes or no answer)
研究概览
简要总结
Patients are randomized into 2 groups. The intervention group which receives preoperative counseling about pain and a control group which does not receive this counseling.
The patients are followed up looking at pain scores and pain experience and satisfaction with pain management for 2 days post operative.
详细描述
- All patients admitted for elective upper and lower limb surgery, will be expected to have a preoperative visit by the anesthetic provider on the day before surgery.
- Those who will have consented to participate in the study will be randomized to either the intervention or control group.
- The intervention group will receive specific preoperative information about pain in private by the principal investigator in addition to the preoperative assessment.
- The following variables will be recorded preoperatively: socio-demographics (age, gender, tribe, education level) and vital signs (pulse rate, blood pressure and oxygen saturation).
- A Numerical pain score will be explained to patient before it is recorded preoperatively.
- The patient will also be informed that the pain scores will be repeated after surgery at (someone will take the pain scores again after surgery at) 0, 6, 12, 24, 48hours or till discharge if less than 48hours. In addition the pulse rate, number of analgesic intravenous/ intramuscular injections or tablets needed/or given will be recorded.
- Assessed pain will be classified as no pain (1-3), pain (4-10) but also as no pain (0), mild (1-3), moderate (4-6) and severe pain (7-10).
- Intra operatively, the anaesthetic technique (general or regional), medications given, duration of surgery will be recorded in) the questionnaires.
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
- Double (Participant, Care Provider)
盲法说明
The participants and the healthcare providers do not know which patient belongs to which arm
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 18 years and above
- •Elective orthopedic surgery patients admitted to orthopedic/trauma ward Mulago hospital
- •Patient who gives consent
排除标准
- •Patients with chronic pain not related to the surgery they are to undergo
- •Patients with bone cancer
- •Inability to speak or hear (deaf or dumb)
- •Previously recruited but comes for re-surgery for same condition
结局指标
主要结局
Post operative pain experience (yes or no answer)
时间窗: 2 days
Patients subjectively tell you if their pain has been adequately controlled with a yes or no answer
Patient satisfaction (answer yes or no)
时间窗: 2 days
Is the patient happy with how the pain has been managed answer yes or no
次要结局
- Time to ambulation(3 days)
研究者
研究点 (2)
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