跳至主要内容
临床试验/NCT03005171
NCT03005171已完成2 期

Perioperative Epidural Versus Intravenous Local Anesthetic Infusion in Open Upper Abdominal Surgery

Assiut University0 个研究点目标入组 70 人开始时间: 2017年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
70
主要终点
Verbal Numeric Rating Score

研究概览

简要总结

The study evaluates the efficacy of intravenous lidocaine as an analgesic modality in patients undergoing open upper abdominal surgery; when compared with thoracic epidural analgesia. Half of participants will receive intravenous lidocaine infusion, while the other half will receive thoracic epidural bupivacaine infusion.

详细描述

Postoperative pain is one of the commonest problems encountered by anaesthesiologists, especially after open abdominal surgeries, in which post-operative pain would cause a restrictive respiratory dysfunction, which is associated with poor postoperative outcomes. Despite the fact that epidural blocks provide superior analgesia; it is not often an ideal option as it frequently causes hypotension that may require excessive intravenous fluid administration, which is particularly deleterious after bowel surgery. Other complications include epidural hematoma and higher failure rate. Furthermore epidural analgesia may be contraindicated in some patients e.g. patients on certain anti-platelet therapy and patients refusing the technique.

Other modalities to control postoperative pain are used e.g. intravenous analgesics and continuous wound infiltration, but none of which was proven to be as effective as epidural block.

Whether perioperative lidocaine infusion is as effective as epidural block in reducing post-operative pain, is this study's concern.

Some researches studied the efficacy of lidocaine infusion in controlling neuropathic as well as acute postoperative pain with encouraging results. Lidocaine infusion was found to reduce postoperative pain, opioid consumption and the length of hospital stay. Although risks of neurological and cardiac toxicity exist, these were not substantiated in the trials.

Lidocaine has been described to have both analgesic, and anti-hyperalgesic effects6, as well as anti-inflammatory properties. It also accelerates the return of post-operative gastrointestinal function, which is of particular importance after major abdominal surgery. Opposite to opioids, which increase the incidence of nausea and vomiting, lidocaine decreases their incidence.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing open upper abdominal surgery

排除标准

  • Bleeding diathesis
  • History of allergy to local anesthetics
  • Pregnancy/ lactation
  • Cardiovascular disease
  • Respiratory disease

研究组 & 干预措施

Epidural

Active Comparator

Epidural catheters will be placed in the 9th or 10th thoracic intervertebral space prior to induction of anesthesia.Through the thoracic epidural catheter 0.125% bupivacaine at a rate of 5 mL/h will be infused.

The infusion continues for 24h

干预措施: Bupivacaine (Drug)

Lidocaine

Active Comparator

Intravenous lidocaine infusion will typically start in the operating room prior to induction of anesthesia at a rate of 2 to 3 mg/min. Postoperatively, the rate will be decreased to 0.5 to 1 mg/min.

The infusion continues for 24h

干预措施: Lidocaine (Drug)

结局指标

主要结局

Verbal Numeric Rating Score

时间窗: 2-24 hours

Verbal Numeric Rating Score is an 11-point scoring system used to assesses the postoperative pain level of the participants

次要结局

  • FEV1(Baseline-24 hours)
  • B- endorphin level(Baseline-24 hours)
  • FVC(Baseline-24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Asmaa Mohamed Moatasem

Assistant Lecturer

Assiut University

相似试验