The Effect of Nalbuphine as an Adjuvant to Levobupivacaine in Subarachnoid Anesthesia in Total Hip Arthroplasty. A Double-blind, Randomized, Controlled Study.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Morphine consumption
研究概览
简要总结
60 patients ASA I-III, undergoing total hip arthroplasty were randomly assigned, into one of two groups, namely group E (n=30), where levobupivacaine will be administeral intrathecally ; and group N (n=30), where levobupivacaine plus nalbuphine will be administeral intrathecally. All patients will receive a standardized multimodal analgesic regimen, including a PENG block and PCA morphine. Morphine consumption during the first 24 hours postoperatively will be measured and additionally the investigators will record: Time of morphine first dose administration, NRS scores in static and dynamic conditions in 4 hours, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours and 48 hours postoperatively, complications, patient satisfaction and duration of hospitalization.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physical status according to American Society of Anesthesiologists (ASA) I-III
- •Patients scheduled for total hip arthroplasty
排除标准
- •BMI above 40
- •Serious psychiatric, mental and cognitive disorders
- •Contraindication for central and/or peripheral nervous blockade
- •History of allergic or other adverse reactions on the agents used in the study
- •Chronic opioid
研究组 & 干预措施
N
Spinal levobupivacaine plus nalbuphine
干预措施: Levobupivacaine plus nalbuphine (Drug)
E
Spinal levobupivacaine
干预措施: Levobupivacaine (Drug)
结局指标
主要结局
Morphine consumption
时间窗: 24 hours
NRS scores
时间窗: 48 hours
次要结局
- motor block onset(1 hour)
- sensory block onset(1 hour)
- sensory block level(1 hour)
- motor block level(1 hour)
- sensory block duration(4 hours)
- motor block duration(4 hours)
- Complications(24 hours)
研究者
Alexandros Makris
Consultant Anaesthesiologist
Asklepieion Voulas General Hospital