Comparison of Intra-articular Infiltration and Gabapentin With Epidural Analgesia After Total Knee Replacement Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- NRS score in rest
研究概览
简要总结
Postoperative pain after total knee replacement surgery is difficult to treat. Mobilisation and hospital discharge might be delayed. Recent research shows that intra-articular infiltration with local anesthetics and perioperative prescription of gabapentin can improve outcome.
Objective of the study: Comparison of mobilisation speed and postoperative NRS-scores of patients after total knee replacement surgery which is treated with epidural analgesia or peroperative infiltration of the knee. Appraisal of the value of gabapentin for reduction of postoperative opiate consumption.
详细描述
Study design:
Prospective randomised study
Study population:
Patients aged eighteen years or older, in whom knee replacement surgery is indicated. They will have spinal anaesthesia and epidural analgesia if indicated by randomisation. They must not have contraindications for epidural analgesia or the used medication in this study.
Intervention:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older and legally responsible
- •Waiting for total knee replacement surgery
- •Informed consent
排除标准
- •Contraindications for epidural analgesia
- •Aortic Valve stenosis
- •Severely compromised cardiac function
- •infection near epidural punction site
- •Redo knee surgery
- •Previous arthrotomies
- •Allergy/Hypersensitivity for study mediation or all other used medication
- •Participation in other studies
研究组 & 干预措施
local infiltration and gabapentin
The third group will receive local infiltration with ropivacaine of the knee during surgery and will additionally be treated with gabapentin.
干预措施: neurontin (Drug)
epidural analgesia
The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced.
干预措施: marcaine (Drug)
epidural analgesia
The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced.
干预措施: sufentanil (Drug)
local infiltration
The second group will receive local infiltration with ropivacaine of the knee during surgery.
干预措施: naropin (Drug)
local infiltration and gabapentin
The third group will receive local infiltration with ropivacaine of the knee during surgery and will additionally be treated with gabapentin.
干预措施: naropin (Drug)
结局指标
主要结局
NRS score in rest
时间窗: 3 days after surgery
次要结局
- NRS score during walking exercise(3 days after surgery)
- Postoperative morphine consumption(3 days after surgery)
- Speed of mobilisation(3 days after surgery)
- NRS score during flexion exercise(3 days after surgery)
研究者
Leon Timmerman
anesthesiologist
St. Antonius Hospital