Nylon Versus Polyurethane Epidural Catheters In Patients Undergoing Major Orthopedic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean and Standard deviation of Time required for epidural catheter insertion (seconds) (mean±SD)
研究概览
简要总结
Objectives: To compare the safety and efficacy of nylon (polyamide) epidural catheter versus polyurethane epidural catheter in patients undergoing major orthopedic surgery under continuous epidural anesthesia.
Background: Continuous epidural anesthesia is the most common anesthetic technique used in orthopedic surgery. However, the use of epidural catheters is associated with complications. The insertion of the catheter may be associated with intravascular or intrathecal placement, nerve root irritation, paresthesia, kinking, hematoma, or breakage during catheter removal.
Patients and Methods: This was a prospective, randomized, double-blind clinical trial; carried out on 60 patients undergoing major orthopedic surgery under continuous epidural anesthesia. Patients were randomly allocated into two equal groups; group N, using Nylon catheter, and group P, using Polyurethane catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status ≤ II
- •Age from 21 to 60 years
- •Body Mass Index (BMI) < 35
排除标准
- •American Society of Anesthesiologists (ASA) physical status > II
- •Age < 21 years or > 60 years
- •Body Mass Index (BMI) ≥ 35
- •Contraindications to regional anesthesia (including coagulopathy and infection at the injection site)
- •Uncooperative patients
- •Patients with known allergy to local anesthetics or opioids
研究组 & 干预措施
Group N (n=30)
Continuous Epidural Anesthesia using Nylon (Polyamide) Epidural Catheter
干预措施: Nylon (Polyamide) Epidural Catheter (Device)
Group P (n=30)
Continuous Epidural Anesthesia using Polyurethane Epidural Catheter
干预措施: Polyurethane Epidural Catheter (Device)
结局指标
主要结局
Mean and Standard deviation of Time required for epidural catheter insertion (seconds) (mean±SD)
时间窗: 2 minutes after identifying the epidural space by loss of resistance technique
Time interval from holding the epidural catheter by the anesthetist till removal of the Tuohy needle through the epidural catheter by the anesthetist
次要结局
- Number of participants and Rate of Catheter-related complications(2 minutes after the end of the operation)
- Mean and Standard deviation of Time required for epidural catheter to anchor with the catheter connector (seconds) (mean±SD)(2 minutes after removal of the Tuohy needle through the epidural catheter)
- Mean and Standard deviation of Time required for epidural catheter removal (seconds) (mean±SD)(2 minutes after the end of the operation)