Postoperative Pain: Is Tunneling Effective in Preventing Failure of Epidural Analgesia? A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Difference in Rate of dislodgment between the two groups
研究概览
简要总结
This is a prospective randomized single blinded study in patients planned to undergo general anesthesia and epidural catheter insertion for pain control after abdominal, thoracic and orthopedic surgery.
Patients meeting participation criteria will be selected and enrolled sequentially.
The study recruitment will be carried out over one year with follow-up for each patient until either the catheter is dislodged or once decided that the patient is to be discontinued from the epidural pain control.
详细描述
Study Population and Sample Size The study aims to enroll 200 adult patients planned to undergo general anesthesia and epidural catheter insertion. The study sample will be selected to fulfill the selection criteria.
Patients will be selected if they meet the following participation criteria:
Planned Procedures and Assessments Follow -up on dislodgments, adverse events, pain and pain relief assessment, standard practice Study Site All study conduction from start to end including procedures and assessments, data acquisition and analysis and final study conclusion report and any publications will be at King Hussein Cancer Center (KHCC).
Ethical Considerations The study will be submitted to the KHCC IRB for review. The study will not start before IRB approval is obtained.
All patients who provide consent to participation in the study will be randomized and enrolled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is an adult, between 18-80 years old with normal mentation.
- •Patient has consented to general anesthesia and epidural catheter insertion for pain control after abdominal, thoracic and orthopedic surgery
- •Patient is able to understand and provide informed consent to participate in the study.
排除标准
- •Patient is prone to coagulopathy.
- •Patient has infection at injection site.
- •Any Patient seen immediately before surgery-
研究组 & 干预措施
tunneling group
Epidural Catheter Insertion and fixation by subcutaneous tunneling procedure.
干预措施: tunneling epidural catheter (Procedure)
taping group
Epidural Catheter Insertion and fixation by use of adhesive tape without tunneling.
干预措施: tunneling epidural catheter (Procedure)
结局指标
主要结局
Difference in Rate of dislodgment between the two groups
时间窗: 5 days
Descriptive statistics will be used to present the two groups baseline characteristics. Comparison between groups will be carried out using Chi-square test or t-test or Wilcox on rank test as appropriate. Comparison between groups while adjusting for other variables will be carried out using logistic regression. Odds ratios along with their 95% confidence intervals will be calculated.
次要结局
- Rate of adverse events(5 days)
- standard numerical pain score (NPS)(5 days)
研究者
Hussein Abu Khudair
chairman department of anesthesiology and pain management
King Hussein Cancer Center