Intrathecal Hyperbaric Prilocaine in Adult Patients Undergoing Knee Arthroscopy, a Randomized Controlled Trail
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Time to void; time from spinal anaesthesia to first void
研究概览
简要总结
The goal of this randomised trial is to use a short acting local anaesthetic drug (hyperbaric prilocaine 2%) which is beneficial in short operations which are performed as a day case surgery.
in this study the investigators will use 3 different doses of prilocaine 2% (40,50 or 60 mg ) intrathecal (in spinal anaesthesia) in participants undergoing arthroscopy on the knee.
the primary outcome is to compare time to micturate (go to the bathroom) between the three groups .
the secondary outcomes are:
- time to recovery of the motor and sensory block
- time to discharge from post anesthesia care unit
- any complications ; itching, lowered blood pressure, nausea and vomiting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients (male/female, American Society of Anesthesiologists physical status I-II, age: 18-60 years) undergoing knee arthroscopy will be eligible for the study. -
排除标准
- •Coagulopathy and other bleeding disorders (INR more than 1.4 and platelet less than 80000)
- •Patient refusal.
- •Infection at the site of injection.
- •Allergies against prilocaine.
- •Increased intracranial pressure.
- •Severe MS and AS.
- •Sever hypovolemia.
研究组 & 干预措施
arm 40
干预措施: Hyperbaric prilocaine 2% 40 mg (Drug)
arm 50
this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in the dose of 50 mg.
干预措施: hyperbaric prilocaine 2% 50 mg (Drug)
arm 60
this arm will include 50 patients who will receive intrathecal hyperbaric prilocaine 2% in the dose of 60 mg
干预措施: hyperbaric prilocaine 2% 60 mg (Drug)
结局指标
主要结局
Time to void; time from spinal anaesthesia to first void
时间窗: from time of spinal anaesthesia as a start point till time for the participant to get up and micturate on his own (time to first void) assessed up to 4 hours postoperative
we will measure the time from spinal anaesthesia to first void and compare that in the 3 groups with different doses of hyperbaric prilocaine 2% (40,50 and 60 mg) to see which group has the least time to void and so early ambulation in a day case surgery of knee arthroscopy.
次要结局
- Motor block regression time(The motor block will be assessed 10 min after intrathecal injection as a start point and every 30 minutes until recovery of full motor power (bromage 0) up to 4 hours postoperative)
- sensory regression time(sensory regression time will be measured 10 minutes after intrathecal block (as a start point) and then every 30 minutes until regression to two dermatomes intra-operative and until 4 hours post-operative.)
- heart rate(heart rate will be measured in the form of beats /min from the start of operation and every 5 minutes till the end of operation)
- mean arterial pressure(mean arterial pressure (MAP) will be measured in mmhg every 5 minutes from the start of operation till the end of operation)
- Incidence of complications(incidence of complications will be recorded from the start of operation till discharge from post anaesthesia care unit (PACU) assessed up to 4 hours)
- Time to discharge from post operative anaesthesia unit (PACU)(time will be recorded from the start of operation till discharge of the participant from PACU after reaching Aldrete score of 10 (up to 4 hours postoperative))
研究者
Alaa mahmoud bahaa eldin mohamed taha
lecturer of anaesthesia , surgical ICU and pain -cairo university
Cairo University