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临床试验/NCT00914498
NCT00914498Unknown不适用

The Effect of Pre-incisional Local Xylocaine Injection on Post Operative Pain and Scar Formation After Cesarean Section

The Baruch Padeh Medical Center, Poriya1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
120
试验地点
1
主要终点
Level of post operative pain on a visual analog scale

研究概览

简要总结

This study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. One hundred and twenty women will be allocated to get 20 ml of either placebo or 1% xylocaine at the site of skin incision. We will also examine possible effect of this infiltration of parameters of wound heeling and scar formation, six weeks post partum.

详细描述

Among all other abdominal operations cesarean section is unique in two aspects. First, the requirement for rapid and as painless as possible recovery is not only important for the general good reasons, but there is the newborn baby, who needs maternal care. Second, in many cases the operation recurs in the same site, which may involve higher level of post operative pain.

Application of local anesthetics to the incision site have been tried for abdominal operation in several forms, ranging from pre-incision injection (1-6) through post incision injection (7 ) to indwelling catheter for protracted instillation (8-9). Where tried, these methods mostly contributed to the reduction of post operative pain and patients' satisfaction, although there is no consensus as to its efficacy. Yet, local, pre-incision injection of local anesthetics has not been tested for cesarean section.

The above not withstanding, it has been proposed that local infiltration of tissue with xylocaine may interfere with wound healing (10-11). Others suggested possible benefit due to antimicrobial activity (12) Conversely, Al- Asfour et al. (13) found no effect of topical oral application of xylocaine on experimental wounds in rabbits. Interestingly, Drucker et al. found that less collagen was deposited in healing wounds that were infiltrated with xylocaine prior to incision, while the strength of the scar was not affected (14-15).

Our proposed study will examine whether pre-incision infiltration of the skin cut site can attenuate post operative pain after a cesarean section. It will also examine possible effect of this infiltration of parameters of wound heeling and scar formation.

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
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Candidates for non-emergency cesarean section

排除标准

  • Emergency cesarean section
  • Known or suspected sensitivity to local anesthetics
  • Pre-eclamptic toxemia
  • Deranged liver function
  • Deranged hemostasis
  • Lack of adequate verbal communication

研究组 & 干预措施

Xylocaine

Experimental

Participants will receive local injection of 20 ml 1% Xylocaine to the skin incision site

干预措施: Local, pre-incisional injection of 20 ml 1% xylocaine (Drug)

Controls

Placebo Comparator

Participants will receive injection of 0.9% NaCl 20 ml to the incision site

干预措施: Local, pre-incisional injection of 20 ml 1% xylocaine (Drug)

结局指标

主要结局

Level of post operative pain on a visual analog scale

时间窗: Up to 48 hours postoperative

次要结局

  • Appearance of operative scar, compared to previous scar(6-8 weeks)

研究者

申办方类型
Other Gov

研究点 (1)

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