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临床试验/NCT03228797
NCT03228797已完成不适用

A Comparison of Postoperative Outcomes Provided by a Continuous Preperitoneal Infusion Versus Ultrasound Guided Transversus Abdominis Plane Block for Abdominoplasty

Dr Manar Mamdouh Fahmy Elsharkawi0 个研究点目标入组 60 人开始时间: 2015年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
主要终点
self reported pain intensity in the morning ,afternoon,evening, during activity over the past 2 days

研究概览

简要总结

aim of this study is to compare the postoperative analgesia provided bya continuous preperitoneal infusion versus ultrasound guided rectus sheath block for midline emergency laparotomy.

anticoagulated patients

详细描述

Patients and Methods:

This randomized prospective study will be carried out after the approval of Rashid Hospital's Research Ethical Committee and patient's written informed consent.

Sixty adult patients , of both gender , 18-70 years old, ASA I-III who will be scheduled for emergency laparotomy with upper abdominal midline incision will be included in the study. Exclusion criteria will be patients with known allergic response or contraindications to paracetamol, parecoxib, morphine or ropivacaine and pregnant women

The enrolled patients will be randomly assigned to one of three groups:

Group I ( 20 patients) will receive an ultrasound guided rectus sheath block by the end of the surgery using 15 ml ropivacaine 0.5% on either side.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

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

  • ASA-1 to ASA-3,emergency midline laparotomy

排除标准

  • ASA-4 & above,allergic patients to the study's medications ,morbid obeses patients,patient refusal,age below 18yrs

研究组 & 干预措施

Group I

Active Comparator

( 20 patients) will receive an ultrasound guided rectus sheath block by the end of the surgery using 15 ml ropivacaine 0.5% on either side.

干预措施: an ultrasound guided rectus sheath block (Procedure)

Group II

Active Comparator

( 20 patients) multiholed catheter will be inserted at the end of surgery and after the closure of the peritoneal layer, a10 ml bolus of ropivacaine 0.2% will be administered through the catheter and then connected to an elastomeric pump delivering a continuous fixed -rate of ropivacaine 5ml/h.

干预措施: multiholed catheter (Procedure)

Group III

Active Comparator

( 20 patients) a multiholed catheter will be inserted as in Group II and will receive also an ultrasound guided rectus sheath block as described for Group I.

干预措施: an ultrasound guided rectus sheath block &multiholed catheter (Procedure)

结局指标

主要结局

self reported pain intensity in the morning ,afternoon,evening, during activity over the past 2 days

时间窗: 2 days

each item is scored (0-10)0=no pain\& 10= the worst

次要结局

未报告次要终点

研究者

发起方
Dr Manar Mamdouh Fahmy Elsharkawi
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Dr Manar Mamdouh Fahmy Elsharkawi

anaesthesiologist

Dubai Health Authority

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