The Effects of Fixation Technique on Thoracic Epidural Catheter Displacement: a Single-Center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Epidural catheter displacement day 1
研究概览
简要总结
The purpose of our study is to assess the effectiveness of Dermabond as a thoracic epidural fixation technique compared to both Mastisol and the Grip-Lok fixation bandage, two common, widely used techniques for epidural fixation.
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
- Single (Participant)
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
- •surgical patient
- •receiving a thoracic epidural
- •18 years of age or older
排除标准
- •Patient refusal
- •allergy to adhesives or local anesthesia
- •pregnancy
- •contraindication to receiving an epidural including coagulopathy, infection, elevated ICP, or severe pre-existing neurologic disorders
研究组 & 干预措施
Dermabond
Catheter fixation will be performed after appropriate placement of a thoracic epidural with Dermabond. The investigator performing the thoracic epidural will distribute the Dermabond at the catheter insertion site in a space no greater than a 2 cm circle around the site. Once the Dermabond is allowed to dry, mastisol will be applied to the surrounding skin and a clear Tegaderm dressing will be used to cover the catheter. Catheter depth at the skin will be recorded at that time. An Epidural catheter infusion pump with 1/8thpercent Bupivacaine and 2mcg/ml Fentanyl will be attached to the catheter and started by the primary anesthesia with a goal rate of 6ml/hr.
干预措施: Thoracic Epidural Catheter Fixation Techniques (Other)
Mastisol
Catheter fixation will be performed after appropriate placement of a thoracic epidural with Mastisol spray. The investigator performing the epidural placement will distribute Mastisol spray both in close proximity to the catheter insertion site as well as around the insertion site. Once the Mastisol is allowed to dry, a clear Tegaderm dressing will be used to cover the catheter. Catheter depth at the skin will be recorded at that time. An Epidural catheter infusion pump with 1/8thpercent Bupivacaine and 2mcg/ml Fentanyl will be attached to the catheter and started by the primary anesthesia team with a goal rate of 6ml/hr.
干预措施: Thoracic Epidural Catheter Fixation Techniques (Other)
Grip-lock
Catheter fixation will be performed after appropriate placement of a thoracic epidural with a Grip-Lok fixation bandage. The investigator performing the epidural placement will place the fixation bandage one centimeter caudal from the insertion site. Mastisol will be applied to the surrounding skin and a clear Tegaderm will then be used to cover the catheter. Catheter depth at the skin will be recorded at that time. An Epidural catheter infusion pump with 1/8thpercent Bupivacaine and 2mcg/ml Fentanyl will be attached to the catheter and started by the primary anesthesia team in the operating room with a goal rate of 6ml/hr.
干预措施: Thoracic Epidural Catheter Fixation Techniques (Other)
结局指标
主要结局
Epidural catheter displacement day 1
时间窗: 24 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Epidural catheter displacement day 2
时间窗: 48 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Epidural catheter displacement immediately after surgery
时间窗: immediately after surgery in PACU
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Epidural catheter displacement day 4
时间窗: 96 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Epidural catheter displacement day 3
时间窗: 72 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Epidural catheter displacement day 5
时间窗: 120 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Epidural catheter displacement day 7
时间窗: 168 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
Epidural catheter displacement day 6
时间窗: 144 hours post-operative
Failure of epidural fixation as measured by catheter depth at the skin (to the nearest 0.5 cm
次要结局
- Leakage(immediately after surgery in PACU and daily until the patient is discharged up to post-operative day 7)
- Percent of patients with skin changes as measured by clinician subjective assessment(immediately after surgery in PACU and daily until the patient is discharged up to post-operative day 7)
- Opioid consumption(daily up to 7 days post-operative)
研究者
Adam Meier
Associate Professor
University of Utah