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临床试验/NCT02725229
NCT02725229已完成不适用

Comparison of Transcutaneous Electrical Nerve Stimulation and Parasternal Block for Postoperative Pain Management After Cardiac Surgery

Antalya Training and Research Hospital2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2011年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Visual Analogue Scores

研究概览

简要总结

the objective of the present study was to compare the efficacy of TENS and parasternal block with local anesthetic infiltration in relieving pain during the first 24 h period following median sternotomy.

详细描述

Patients experiencing pain after undergoing cardiac surgery may also experience prolonged immobilization, insufficient respiratory functions and the inability to cough due to median sternotomy. Invasive and noninvasive interventions such as epidural analgesia, local regional blockade and the use of intravenous (IV) opioids, are used for postoperative pain management. Transcutaneous electrical nerve stimulation (TENS) is a noninvasive technique that is effective for postoperative pain management. It has been demonstrated to produce effective analgesia and reduce postoperative opioid requirements in patients undergoing cardiac surgery, and it has no side effects. Parasternal local anesthetic infiltration around the sternum has been demonstrated to be useful in providing early postoperative analgesia, reducing opioid requirements and, therefore, producing a potential positive effect on recovery. The present prospective, randomized controlled study included 120 patients, 18 to 65 years of age, who were scheduled for elective valve repair or coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass. A random number table was used to randomly allocate patients to one of three treatment groups to relieve postoperative pain during the first 24 h following median sternotomy: parasternal block group (parasternal block combined with levobupivacaine infiltration and PCA(patient controlled analgesia)); TENS group (TENS and PCA); or the control group (PCA alone).

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 to 65 years of age,
  • who were scheduled for elective valve repair or coronary artery bypass graft (CABG) surgery with cardiopulmonary bypass

排除标准

  • previous sternotomy for CABG or heart valve surgery; emergency surgery
  • ejection fraction <40%
  • congestive heart failure
  • an allergy to amide-based local anesthetics, opioids or benzodiazepines
  • inability to provide informed consent
  • prolonged cardiopulmonary bypass time (>145 min)
  • previous experience with TENS

结局指标

主要结局

Visual Analogue Scores

时间窗: Assessed 24 hours after to intensive care unit admission

次要结局

  • Supplemental morphine used(Assessed 24 hours after to intensive care unit admission)
  • Supplemental tramadol used(Assessed 24 hours after to intensive care unit admission)
  • Extubation time(Assessed 24 hours after to intensive care unit admission)
  • Length of ICU stay(Assessed 24 hours after to intensive care unit admission)
  • Length of hospital stay(Assessed 10 days after to intensive care unit admission)

研究者

发起方
Antalya Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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Parasternal Block and TENS for Cardiac Surgery | 临床试验