Comparing Effectiveness of Post-operative Analgesia Between Patient Re-education and the Additional of a Basal Morphine Infusion to IV-PCA Morphine in Patients With Unsatisfactory Analgesia After Laparotomy
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- measure pain intensity at rest and when blowing incentive spirometer (dynamic pain)
研究概览
简要总结
The purpose of this study is to improve IV-Patient Controlled Analgesia (IV-PCA) technique for postoperative analgesia. Investigators are comparing between patient re-education and the background morphine infusion among patients who fail to achieve satisfactory analgesia using IV-PCA Morphine after laparotomy.
详细描述
In this study, investigators have a second inclusion criteria for subject recruitment. For subjects who meet this criteria meaning their dynamic pain (when blowing incentive spirometer) is ≥ 4/10 after starting on IV-PCA Morphine will be randomized in to 2 groups. One group will receive patient re--education with an additional background morphine infusion and the other group will receive re--education only.
The second highlight for this study is regarding the background morphine calculation. The background morphine is calculated according to this formula:
Total morphine requirement in the first 24 hours post surgery (mg) = 100 - Age (year) So, the background morphine infusion will be calculated based on subject's age and half of their 24 hours requirement will be infused over 24 hours.
This formula was published by Pamela Macintyre in her paper titled " Age is the Best Predictor of Postoperative Morphine Requirement".
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)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA)Physical Status Classification Class I and II
- •Elective laparotomy
- •able to understand either malaysia, mandarin, english language or local dialect
- •patient with dynamic pain score 4/10 and more within the first 4-hour after initiation of IV-PCA
排除标准
- •patient refusal
- •laparotomy with pfannenstiel incision
- •patients with a history of allergy to opioids
- •patients who required post-operative ventilation support
- •patients ASA III and above
- •patients unable to use PCA due to insufficient comprehension
- •morbid obesity/ obstructive sleep apnea
- •chronic opioid or alcohol abuse
研究组 & 干预措施
Background morphine infusion to IV-PCA Morphine
Calculate based on patient's age, in mg/hour
干预措施: morphine (Drug)
Background morphine infusion to IV-PCA Morphine
Calculate based on patient's age, in mg/hour
干预措施: Patient re-education (Behavioral)
Patient re-education to IV-PCA Morphine
Using patient information leaflet
干预措施: Patient re-education (Behavioral)
结局指标
主要结局
measure pain intensity at rest and when blowing incentive spirometer (dynamic pain)
时间窗: 48 hours after surgery
use combination of Numerical Rating Scale(NRS) and Visual Analogue Scale(VAS)
次要结局
- respiratory rate(48 hours after surgery)
- total accumulative morphine consumption from IV-PCA pump(48 hours after surgery)
- sedation level(48 hours after surgery)
研究者
Yeoh Lee Choo
Anaesthesiologist
Clinical Research Centre, Malaysia