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A Comparison of Postoperative Outcomes Provided by a Continuous Preperitoneal Infusion Versus Ultrasound Guided Rectus Sheath Block for Midline Emergency Laparotomy

2017年8月24日 更新者:Dr Manar Mamdouh Fahmy Elsharkawi

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

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

研究概览

详细说明

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.

Group II ( 20 patients) for whom a 7.5 , 15 , 30 cm 19-gauge multiholed catheter will be inserted at the end of surgery and after the closure of the peritoneal layer at 3 to 5 cm away from the lower end of the surgical incision through an introducer peel-away needle. The length of the catheter will be established to guarantee homogenous distribution of the holes all along the length of the incision of the fascia. The catheter will be allocated above the peritoneum within the musculofascial layer and secured to the skin with an occlusive transparent dressing. A 10 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 10 ml/h.

Group III( 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.

No premedication will be administered. General anesthesia will be induced using target controlled intravenous infusion (TCI) using remifentanil (1-10 ng/ml effect concentration ) and propofol ( 1-10 mcg/ml effect concentration) titrated to Bi-spectral index (BIS) value between 40-60.Once anesthesia level will be reached , succinyl choline 1mg/kg intravenously will be given. After the airway will be secured , TCI will be adjusted to maintain BIS value between 40 to 60.An initial dose of 0.1 mg/kg intravenous cisatracurium will be administered and further doses will be given according to neuromuscular monitoring maintaining a train of four (TOF) value of zero.

Pre-incision , all patients will receive 15 mg/kg intravenous bolus and 40 mg intravenous parecoxib. 0.5 mg intravenous ketamine will be administered to avoid remifentanil's induced hyperalgesia.

All patients will be mechanically ventilated to maintain normocapnia throughout the procedure. Standard intraoperative monitoring will include electrocardiography, pulse oximetry , automatic non-invasive blood pressure , end tidal capnography , Bi-spectral index and train of four monitoring.

At the end of surgery and before extubation , patients who will be randomly assigned to Group I will receive an ultrasound-guided bilateral rectus sheath block using 15 ml of ropivacaine 0.5% on each side.

For patients who will be assigned to either Group II or Group III , a 7.5 , 15 or 30 cm 19-gauge multiholed catheter will be inserted by the operating surgeon at the end of surgery and after the closure of the peritoneal layer at 3 to 5 cm away from the lower end of the surgical incision through an introducer peel-away needle. The length of the catheter will be established to guarantee homogenous distribution of the holes all along the length of the incision of the fascia. The catheter will be allocated above the peritoneum within the musculofascial layer and secured to the skin with an occlusive transparent dressing. A 10 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 10 ml/h.

For patients who will be assigned to Group III will receive also an ultrasound-guided bilateral rectus sheath block using 15 ml of ropivacaine 0.5% on each side.

Then the patients will be extubated and shifted to Post-Anesthesia Care Unit (PACU) where they will be monitored for heart rate , blood pressure , oxygen saturation by pulse oximetry and pain score using visual analogue scale (VAS) both at rest and deep breathing . These data will be recorded every 15 minutes for the first hour.

After one hour , the patients will be discharged from PACU according to Modified Aldrete Scoring if they will reach a score of 9 or more. All patients will receive parecoxib 40 mg intravenously twice a day and paracetamol in a dose of 40 mg/kg intravenously in three divided doses regularly for 48 hours postoperatively.

In the postoperative period, all the patients will be evaluated for their hemodynamic variables ( heart rate , respiratory rate , arterial blood pressure and arterial oxygen saturation ) and postoperative analgesia using VAS at rest and with deep breathing at 2,4,8,12,18,24,36 and 48 hours postoperatively.

If the patient's VAS will reach 4 at any time in the 48 hours postoperatively, 0.1 mg/kg titrated intravenous morphine rescue analgesia will be administered and repeated if required to maintain VAS less than 4.

All patients will respond to a quality of life questionnaire (QR 40) at 24 and 48 hours postoperatively.

研究类型

介入性

注册 (实际的)

60

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器: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.
其他名称:
  • naropine 0.5%
有源比较器:Group II
( 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.
gauge multiholed catheter will be inserted at the end of surgery and after the closure of the peritoneal layer at 3 to 5 cm away from the lower end of the surgical incision
其他名称:
  • 那洛品 0.2%
有源比较器:Group III
( 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.
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.
其他名称:
  • naropine 0.5% & naropine/ropivacaine 0.2%

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
self reported pain intensity in the morning ,afternoon,evening, during activity over the past 2 days
大体时间:2 days
each item is scored (0-10)0=no pain& 10= the worst
2 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:DR.HANY GREISS, consultant、DHA -Rashid hospital
  • 首席研究员:DR.MANAR MAMADOUH, specialist、DHA -Rashid hospital
  • 研究主任:DR.MANSOUR NADHRI, consultant、DHA -Rashid hospital
  • 研究主任:DR.OSAMA ALANI, senior specialist、DHA -Rashid hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年2月11日

初级完成 (实际的)

2016年9月1日

研究完成 (实际的)

2016年9月1日

研究注册日期

首次提交

2017年7月6日

首先提交符合 QC 标准的

2017年7月24日

首次发布 (实际的)

2017年7月25日

研究记录更新

最后更新发布 (实际的)

2017年8月25日

上次提交的符合 QC 标准的更新

2017年8月24日

最后验证

2017年8月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

未定

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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