Randomized Study of the Use of Synera for Pain Relief During Local Lidocaine Needle Skin Infiltration for Epidural Placement in Subjects Undergoing Elective Cesarean Section.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Rating of pain intensity upon lidocaine infiltration
研究概览
简要总结
Local infiltration with lidocaine prior to epidural placement for cesarean section, although brief, can be painful. This pain can lead to increased anxiety and distress, adversely affecting patient's overall experience. This study proposes to examine the application of Synera pain patch prior to lidocaine infiltration to reduce this pain and anxiety.
The primary objective of this study is to determine the effect of the Synera on maternal experience during epidural placement. The efficacy of Synera pain patch in reducing subject pain during skin infiltration with lidocaine prior to epidural placement in subjects presenting for scheduled cesarean section will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Over 18 years old;
- •Undergoing pre-scheduled cesarean section;
- •Expected singleton birth;
- •BMI <=35kg.m-2;
排除标准
- •Undergoing emergency cesarean section;
- •Complications during pregnancy;
- •History of hypersensitivity to study medication(lidocaine or tetracaine) or para-aminobenzoic acid;
- •Allergies to bird proteins, feathers, or egg products; or any other skin allergies; dermatitis an open wound at the patch site or a history of difficult epidural placement;
研究组 & 干预措施
Synera
Synera Pain Patch
干预措施: Synera (Drug)
Control
Sham
干预措施: Synera (Drug)
结局指标
主要结局
Rating of pain intensity upon lidocaine infiltration
时间窗: 30 minutes (following patch placement , upon lidocaine infiltration)
次要结局
- Subject anxiety(1 hour (Upon admission to surgical holding area and after epidural placement))