Comparative of Postoperative Pain Control at 24 and 48 Hours Between Intrathecal 0.1 mg. of Morphine or Local Infiltration of 20 ml. of 0.25% Bupivacaine in Patients Post Hip Hemiarthroplasty Under Spinal Anesthesis
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The Amount of Morphine consumption after Hemiarthroplasty
研究概览
简要总结
Falls are a common problem in elderly people which they have to receive the operation. Hemiarthroplasty is one of the common orthopedics operations. The prompt operation and good pain control will provide the good recovery and outcome. The investigators compare the efficacy of postoperative pain control between Intrathecal morphine 0.1 milligrams (mg.) with the local infiltration of 0.25% Bupivacaine for 20 milliliters (ml.) in patients received hip hemiarthroplasty under spinal anesthesia.
详细描述
Study process All the patients who assigned the hip hemiarthroplasty without any exclusion criteria will be enrolled in the study and be divided into 3 groups randomly
- control group : the patients will be received spinal anesthesia with 0.5% Isobaric Bupivacaine and postoperative pain control by intravenous (IV) Patient - control Analgesia (PCA)
- Morphine group : the patients will be received 0.1 mg. of Morphine added in Isobaric Bupivacaine for spinal anesthesia and postoperative pain control by IV PCA
- Local group : the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA
Data collection
- Demographic data : age, sex, Body Weight, Body Mass Index (BMI), ...
- Pain score every 3 hours postoperatively in the first 6 hours and at the 12th hours by visual analogue scoring system
- Patient global assessment and patient satisfactory visual analogue scoring system at 24th and 48th hour
- the amount of morphine during 24 and 48 hours postoperative and the time of first dose they received
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18-90 years
- •Co-operative, able to use PCA
- •ASA classification 1-3
- •no contraindication for Spinal Anesthesia
- •patient acceptance for spinal anesthesia
- •body weight > 30 kg.
- •BMI between 20-35
- •no history of drug allergy, e.g. Local Anesthetics, Paracetamol, etc.
排除标准
- •age > 90 years
- •previous Hemiarthroplasty (the same site)
- •pathological fracture such as severe infection, bone cancer
研究组 & 干预措施
control
The patient will be performed spinal anesthesia alone, with postoperative PCA
干预措施: control (Other)
Morphine
The patient will received intrathecal Morphine for 0.1 mg. in Isobaric bupivacaine in spinal anesthesia and postoperative PCA
干预措施: morphine (Drug)
bupivacaine
the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA
干预措施: Bupivacaine (Drug)
结局指标
主要结局
The Amount of Morphine consumption after Hemiarthroplasty
时间窗: 24 hours
次要结局
- Efficacy of pain control(48 hours)
研究者
Aphichat Suphathamwit,
Lecturer
Mahidol University