Comparison of Safety Profile and Efficacy of Different Doses of Intrathecal Morphine in Total Hip Replacement.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 3
- 主要终点
- Analgesic efficacy
研究概览
简要总结
Pain management after total hip replacement is one of the most important aspects of postoperative care for patients and clinicians alike. One of the most common techniques used in anesthesia for this procedure is spinal anesthesia with concurrent administration of opioids into spinal sac. Addition of opioids not only prolongs the anesthesia but also provides pain relief after the procedure for a limited amount of time. Because of its unique chemical properties morphine provides the longest pain relief amongst currently known opioids lasting up to 24 hours. Unfortunately this beneficial effect is associated with both minor and serious adverse effects, most important of which is respiratory depression.
To limit this potenitialy fatal adverse effect dosing of morphine must be very precise in order to balance advantages and risks.
The aim of the study was to assess effectiveness and safety profile of different doses of morphine administered during spinal anesthesia for pain control.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent to participate in trial
- •Qualification for total hip replacement surgery
- •ASA physical status I-III
- •BMI 19-30
- •Lack of contraindications for drugs and interventions used in trial
排除标准
- •Incapability to provide informed consent
- •Contraindications for spinal anesthesia
- •Preoperative chronic pain
- •Chronic use of analgesics
- •Obesity (BMI>30)
- •Allergies and other contraindications for drugs used in trial
- •Mental or physical incapability to operate PCA syringe pump
研究组 & 干预措施
M50
In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
干预措施: Spinal Anesthesia (bupivacaine) (Procedure)
M50
In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
干预措施: Postoperative pain management with acetaminophen (Drug)
M50
In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
干预措施: PCA IV Oxycodone (Device)
M50
In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
干预措施: Postoperative pain management with dexketoprofen (Drug)
M50
In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
干预措施: Postoperative pain management with metamizole (Drug)
M50
In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
干预措施: Preemptive Analgesics (Drug)
M50
In addition to bupivacaine patients received 50 mcg morphine sulphate intrathecaly.
干预措施: Patient monitor (Device)
M100
In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
干预措施: Spinal Anesthesia (bupivacaine) (Procedure)
M100
In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
干预措施: Postoperative pain management with acetaminophen (Drug)
M100
In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
干预措施: PCA IV Oxycodone (Device)
M100
In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
干预措施: Postoperative pain management with dexketoprofen (Drug)
M100
In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
干预措施: Postoperative pain management with metamizole (Drug)
M100
In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
干预措施: Preemptive Analgesics (Drug)
M100
In addition to bupivacaine patients received 100 mcg morphine sulphate intrathecaly.
干预措施: Patient monitor (Device)
M150
In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
干预措施: Spinal Anesthesia (bupivacaine) (Procedure)
M150
In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
干预措施: Postoperative pain management with acetaminophen (Drug)
M150
In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
干预措施: PCA IV Oxycodone (Device)
M150
In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
干预措施: Postoperative pain management with dexketoprofen (Drug)
M150
In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
干预措施: Postoperative pain management with metamizole (Drug)
M150
In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
干预措施: Preemptive Analgesics (Drug)
M150
In addition to bupivacaine patients received 150 mcg morphine sulphate intrathecaly.
干预措施: Patient monitor (Device)
结局指标
主要结局
Analgesic efficacy
时间窗: 48 hours postoperatively
Analgesic efficacy defined as mean value of NRS (Numerical Rating Scale) at 4, 8, 12 ,24 and 48 hours postoperatively at rest and during rehabilitation/movement.
Safety profile
时间窗: 48 hours postoperatively
Frequency of adverse events including excessive sedation (defined as Richmond Agitation Sedation Score RASS≤-1), constipation, postoperative nausea and vomiting, pruritus and respiratory depression defined as sudden drop in respiration rate by ≥90% for ≥10 seconds or cyanosis.
次要结局
- Patient satisfaction(48 hours postoperatively)
- Length of stay(Up to one week.)
- Time to rescue analgesia(48 hours postoperatively)
- Cumulative dose of oxycodone(48 hours postoperatively)