Route of Dexamethasone Administration in iPACK and ACB for Total Knee Replacement: A Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Time to first rescue analgesia
研究概览
简要总结
"The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in iPACK With ACB for Total Knee Arthroplasty" - written in plain language according to ClinicalTrials.gov standards:
The goal of this clinical trial is to learn how the route of dexamethasone administration (either through the vein or nerve block) affects pain and inflammation in people having total knee replacement surgery. All participants will receive two types of nerve blocks before surgery: an iPACK block and an adductor canal block (ACB), which help control pain after the operation.
The main questions the study aims to answer are:
Does injecting dexamethasone into the nerve block reduce pain more effectively than giving it by vein? Which method leads to a lower inflammatory response after surgery? Researchers will compare the two groups to see which route offers better pain relief and less swelling after knee surgery.
Participants will:
Be randomly assigned to receive dexamethasone either in the nerve block or by IV Receive standard care for total knee replacement Rate their pain and have blood tests after surgery to measure inflammation
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 100 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for total knee arthroplasty
- •patients aged >65 and <100 years
- •patients can provide informed consent
- •patients can reliably report symptoms to the research team
排除标准
- •inability to provide first-party consent due to cognitive impairment or a
- •language barrier
- •infection at the site of the regional block,
- •coagulation disorders,
- •immunodeficiency,
- •American Society of Anesthesiologists (ASA) physical status of IV or higher,
- •history of regular steroid medication.
研究组 & 干预措施
Control
iPACK block with ACB
干预措施: NaCl 0.9% (Drug)
iv DEX
iPACK block with ACB + iv Dexamethasone
干预措施: Dexamethasone 4mg (Drug)
pn DEX
iPACK block with ACB + perineural Dexamethasone
干预措施: Dexamethasone 4mg (Drug)
结局指标
主要结局
Time to first rescue analgesia
时间窗: Time Frame: 48 hours after surgery
Time to first rescue analgesia
次要结局
- Total opioid consumption(48 hours after surgery)
- NRS(48 hours after surgery)
- NLR(48 hours after surgery)
- PLR(48 hours after surgery)
- Quadriceps muscle strength assessed using medical research council scale [range 0:5](48 hours after surgery)
- Nerve damage(48 hours after surgery)
- glucose(48 hours after surgery)
- NRS(4 hours after surgery)
- NRS(8 hours after surgery)
- NRS(12 hours after surgery)
- NRS(24 hours after surgery)
- NLR(12 hours after surgery)
- NLR(24 hours after surgery)
- PLR(12 hours after surgery)
- PLR(24 hours after surgery)
- Quadriceps muscle strength assessed using medical research council scale [range 0:5](4 hours after surgery)
- Quadriceps muscle strength assessed using medical research council scale [range 0:5](8 hours after surgery)
- Quadriceps muscle strength assessed using medical research council scale [range 0:5](12 hours after surgery)
- Quadriceps muscle strength assessed using medical research council scale [range 0:5](24 hours after surgery)
- Nerve damage(12 hours after surgery)
- Nerve damage(24 hours after surgery)
- glucose(12 hours after surgery)
- glucose(24 hours after surgery)