Analgesic Effects of Three Different Doses of Intrathecal Ketamine as an Adjuvant to Intrathecal Bupivacaine in Patients Undergoing Knee Arthroscopy. A Randomized Prospective Double-blinded Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Time to first analgesic request
研究概览
简要总结
The aim of this study is to compare the postoperative analgesic effect of three different doses of intrathecal ketamine as an adjuvant to bupivacaine in patients undergoing knee arthroscopy.
详细描述
A meta-analysis of adult human randomized controlled studies that compared single dose perioperative intrathecal ketamine plus intrathecal bupivacaine to bupivacaine alone in spinal anesthesia suggests that there is a benefit to using intrathecal ketamine as an adjunct to bupivacaine in multimodal analgesia. However, there are still knowledge and experience gaps regarding neuraxial ketamine dosing in this regard.
Aim of the study:
The aim of this study is to compare the postoperative analgesic effect of three different doses of intrathecal ketamine as an adjuvant to bupivacaine in patients undergoing knee arthroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-70 years.
- •BMI: 20-30 kg.m2
- •Sex: both males and females.
- •ASA physical status: I-III.
- •Operation: knee arthroscopy.
排除标准
- •Patient's refusal to participate in the study.
- •Aged less than 18 years,
- •known allergy to L.A.,
- •Coagulopathy or thrombocytopenia,
- •height less than 150 cm, morbidly obese infection at the site of injection.
- •Chronic pain syndromes,
- •pregnant woman
- •Patients on regular use of analgesic or who received analgesic 24 h before surgery.
研究组 & 干预措施
Ketamine 0.1
Group I: will include 35 patients, will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.1 mg/kg
干预措施: Ketamine 0.1 mg (Drug)
Ketamine 0.2
Group II will include 35 patients, will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.2 mg/kg
干预措施: Ketamine 0.2 mg (Drug)
Ketamine 0.3
Group III will include 35 patients, will receive 3mL of bupivacaine (heavy) 0.5% in addition to 0.5 ml of a preservative-free ketamine 0.3 mg/kg
干预措施: Ketamine 0.3 mg (Drug)
结局指标
主要结局
Time to first analgesic request
时间窗: First 24 hours
From the time of intrathecal administration of the drug to the time of patient needs the first rescue analgesic drug
次要结局
未报告次要终点
研究者
Mostafa Samy Abbas
associate professor of anesthesia
Assiut University