A Comparison of Peripheral Nerve Catheter Securement Techniques at the Insertion Site in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Force required to dislodge catheter by 1 centimeter
研究概览
简要总结
Continuous peripheral nerve block catheters are used for prolonged analgesia, but are often associated with complications such as catheter failure or dislodgement. This is a single center, prospective study to compare peripheral nerve catheter securement techniques at the insertion site in healthy volunteers.
详细描述
This study will involve the placement of subcutaneous peripheral nerve catheters in healthy volunteers utilizing 6 different securement techniques. The primary outcome is the force required to dislodge the peripheral nerve catheter by 1 centimeter as measured by a dynamometer in Newtons. The secondary endpoint will be the force required to disrupt the catheter dressing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-85 years
- •American Society of Anesthesiologists Physical Status I-II
- •BMI 18-30 kg/m2
排除标准
- •Inability to cooperate with or understand protocol
- •Inability to understand or speak English
- •Allergy to adhesive or tape
- •Local infection in lower extremities
- •Neurologic deficit or disorder
- •Anticoagulation
研究组 & 干预措施
Dressing
Transparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone
干预措施: Dressing (Other)
Dressing + adhesive
Transparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM, Devon, UK) at insertion site
干预措施: Dressing + adhesive (Other)
Dressing + adhesive + strips (parallel)
Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed parallel to long axis of catheter
干预措施: Experimental: Dressing + adhesive + strips (parallel) (Other)
Dressing + adhesive + strips (perpend)
Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed perpendicular to long axis of catheter
干预措施: Experimental: Dressing + adhesive + strips (perpend) (Other)
Dressing + adhesive + strips + benzoin
Transparent film dressing + topical skin adhesive + skin closure strips + topical benzoin (Compound Tincture of Benzoin USP 10%, Professional Disposables International, Inc., Orangeburg, NY, USA) spread in a 12 centimeter by 14 centimeter area around the insertion site
干预措施: Experimental: Dressing + adhesive + strips + benzoin (Other)
Dressing + adhesive + strips + spray
Transparent film dressing + topical skin adhesive + skin closure strips + medical adhesive spray (AdaptTM Medical Adhesive, Hollister Incorporated, Libertyville, IL, USA) in a 12 centimeter by 14 centimeter area around the insertion site
干预措施: Experimental: Dressing + adhesive + strips + spray (Other)
结局指标
主要结局
Force required to dislodge catheter by 1 centimeter
时间窗: 1 study day
This force will be measured using a dynamometer in Newtons
次要结局
- Force required to disrupt catheter dressing(1 study day)