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Study to Test the Efficacy of Periarticular Levo Bupivicaine Injection Following Primary Hip Arthroplasty

A Double Blind Randomized Control Trial on the Efficacy of Periarticular Levo Bupivicaine Injection Following Primary Hip Arthroplasty

The hypothesis of this study is that isolated use of local periarticular levobupivicaine injection during primary hip arthroplasty would improve post-operative pain control. Patients were randomised in the operating room to receive either a periarticular infiltration, or a placebo consisting of Saline. Morphine and analgesic consumption was recorded for each patient, while the modified McGill pain scale was used to determine the adequacy of analgesia and the benefit of the peri-articular infiltration. 91 patients were recruited, with 45 patients in the treatment group and 46 controls. The results were assessed after one year, once all the information from both treatment groups was collected.

研究概览

地位

完全的

条件

详细说明

The efficacy of periarticular injections during total knee arthroplasty is well established but there is little published data on their effect in primary hip arthroplasty. We hypothesized that isolated use of local periarticular levobupivicaine injection during primary hip arthroplasty would improve post-operative pain control. A double blinded, randomised, placebo-controlled trial on patients undergoing primary hip arthroplasty was performed. Patients were randomised in theatre to receive either a periarticular infiltration of 150mg levobupivicaine in 60mls of 0.9% Saline, or a placebo consisting of 60mls 0.9% Saline. Morphine and analgesic consumption was recorded for each patient, while the modified McGill pain scale was used to determine the adequacy of analgesia and the benefit of the peri-articular infiltration. 91 patients were recruited, with 45 patients in the treatment group and 46 controls. The results were assessed after one year, once all the information from both treatment groups was collected.

研究类型

介入性

注册 (实际的)

91

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Finglas
      • Dublin、Finglas、爱尔兰、Dublin 11
        • Cappagh National Orthopaedic Hospital
    • Santry
      • Dublin、Santry、爱尔兰、Dublin 9
        • Orthopaedic Research and Innovation Foundation

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 及以上 (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:

  • Consecutive patients undergoing primary hip arthroplasty for osteoarthritis only were included in this study after giving informed consent.

Exclusion Criteria:

  • Patients with cognitive impairment, neurological disorders, advanced liver or renal impairment, known ischemic heart disease, a previous diagnosis of a pain syndrome or any post-operative surgical or medical complications were excluded.

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:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Levobupivacaine
Levobupivacaine is indicated for local anaesthesia including infiltration, nerve block, ophthalmic, epidural and intrathecal anaesthesia in adults; and infiltration analgesia in children
The treatment group received 150mg of levobupivicaine in 60mls of 0.9% saline. This was injected intra-operatively through the medial and anterior capsular spaces in the region of the obturator and femoral nerves and also around the short rotators and gluteus maximus in the region of the inferior and superior gluteal nerves. The timing of this was after insertion of the acetabular component. 10mls was then infiltrated around the tensor fascia lata and subcutaneously prior to closing the wound.
安慰剂比较:Saline
Saline (also saline solution) is a general term referring to a sterile solution of sodium chloride (NaCl, more commonly known as salt) in water but is only sterile when it is placed intravenously, otherwise, a saline solution is a salt water solution.
The placebo group received 60mls of 0.9% saline injected intra-operatively through the medial and anterior capsular spaces in the region of the obturator and femoral nerves and also around the short rotators and gluteus maximus in the region of the inferior and superior gluteal nerves. The timing of this was after insertion of the acetabular component. 10mls was then infiltrated around the tensor fascia lata and subcutaneously prior to closing the wound.

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
To determine a significant difference (p>0.05) in morphine consumption between the two treatment groups post-operatively.
大体时间:1 year
The modified McGill pain scale was administered to determine the adequacy of analgesia and the benefit of the peri-articular infiltration. In addition, morphine and analgesic consumption was recorded for each patient. The results were assessed after one year, once all the information from both treatment groups was collected.
1 year

次要结果测量

结果测量
大体时间
To analyse the length of stay for between both treatment groups
大体时间:Average 6 days (based on precise day of discharge)
Average 6 days (based on precise day of discharge)

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:Kevin J Mulhall、Orthopaedic Research and Innovation Foundation, Ireland

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2008年9月1日

初级完成 (实际的)

2009年9月1日

研究完成 (实际的)

2009年9月1日

研究注册日期

首次提交

2010年4月12日

首先提交符合 QC 标准的

2010年4月16日

首次发布 (估计)

2010年4月19日

研究记录更新

最后更新发布 (估计)

2010年4月19日

上次提交的符合 QC 标准的更新

2010年4月16日

最后验证

2008年7月1日

更多信息

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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