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Effect of Locally Administered Morphine and Bupivicaine on Acute and Chronic Postmastectomy Pain

2015年12月29日 更新者:Shereen Mamdouh、Assiut University
This study investigate the effect of addition morphine to locally instillation bupivacaine on developing chronic neuropathic pain acute postoperative pain after breast cancer surgery and on the probability of developing chronic neuropathic pain.

研究概览

详细说明

Breast cancer is one of the most common cancer diagnoses in women and a significant cause of mortality and morbidity worldwide.Surgical treatment indicated in most patients. Persistent pain and sensory disturbances following surgery is a significant clinical problem with an average prevalence of 20-23.9%. Post-mastectomy chronic pain syndrome (PMPS) is defined as pain of neuropathic character located in the area of surgery and/or the ipsilateral arm, present at least 4 days per week, and with an average intensity of at least 3 on a numeric rating scale from 0 to 10. The pathological mechanisms may be related to patient characteristics, surgical technique and adjuvant therapy. Although the genesis of pain is multi-factorial, sectioning of the intercostobrachial nerve (a cutaneous branch of T1-2) is the nerve lesion diagnosed most often.

Uncontrolled acute postoperative pain is defined as an important risk factor for the development of chronic pain. Local anesthetics have been investigated in cancer breast patients through many routes; paravertebral blocks, thoracic epidurals, wound infiltration, topical lidocaine patch, and the topical application of EMLA( Eutectic Mixture of Local Anesthetics) cream on operation site. Most of above studies suggested a better outcome in terms of reduced postoperative pain and improved patient satisfaction.

Opioids exert a local analgesic effect is based on several observations: • Nociceptive afferent nerve fibers contain peripheral opioid receptors which are silent except in the presence of local inflammation. • Morphine and its metabolites are largely undetectable systemically when applied topically to skin ulcers, suggesting the analgesic effect is local • Peripheral opioid injections for local analgesia, such as intra-articular morphine after knee surgery, have been found to be effective in several trials. An effective topical opioid analgesic that could be applied to inflamed or open skin lesions would be a useful option for some patients where other options for pain relief have been exhausted.

研究类型

介入性

注册 (实际的)

120

阶段

  • 阶段2

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

      • Assiut、埃及、171516
        • Assiut University

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

30年 至 60年 (成人)

接受健康志愿者

有资格学习的性别

女性

描述

Inclusion Criteria:

  • female patients with cancer breast scheduled for modified radical mastectomy with axillary dissection

Exclusion Criteria:

  • allergy to the study drugs
  • significant cardiac, respiratory, renal or hepatic disease
  • drug or alcohol abuse
  • psychiatric illness that would interfere with perception and assessment of pain

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:交叉作业
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:local instillation of morphine 5 mg
5 ml plain bupivacaine 0.5% and 5 mg morphine .Study drugs will be diluted by saline 0.9% to 20 ml volume and irrigated onto the surgical field before skin closure and suction drain will be closed for 30 min after skin closure.
comparison between different drug doses effects on pain
其他名称:
  • 硫酸吗啡
有源比较器:local instillation of morphine 10 mg
5 ml plain bupivacaine 0.5% and 10 mg morphine .Study drugs will be diluted by saline 0.9% to 20 ml volume and irrigated onto the surgical field before skin closure and suction drain will be closed for 30 min after skin closure.
comparison between different drug doses effects on pain
其他名称:
  • 硫酸吗啡
有源比较器:local instillation of morphine 15 mg
5 ml plain bupivacaine 0.5% and 15 mg morphine .Study drugs will be diluted by saline 0.9% to 20 ml volume and irrigated onto the surgical field before skin closure and suction drain will be closed for 30 min after skin closure.
comparison between different drug doses effects on pain
其他名称:
  • 硫酸吗啡
安慰剂比较:local instillation of local anesthetics
5 ml plain bupivacaine 0.5% .Study drugs will be diluted by saline 0.9% to 20 ml volume and irrigated onto the surgical field before skin closure and suction drain will be closed for 30 min after skin closure.
comparison between different drug doses effects on pain
其他名称:
  • 硫酸吗啡

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
changes in acute pain intensity from the baseline
大体时间:at 2,4,6,12,24,36 and 48 hour postoperatively
Visual analogue pain scale score at rest (VAS-R) and during movement or ipsilateral arm abduction (VAS-M), will be assessed at the same points score ranging from 0 to 10 (zero = no pain and 10 = the worst pain imaginable).
at 2,4,6,12,24,36 and 48 hour postoperatively

次要结果测量

结果测量
措施说明
大体时间
Postoperative adverse effects
大体时间:2,4,6,12,24,36 and 48 hour postoperatively.
nausea, vomiting respiratory depression, itching and sedation
2,4,6,12,24,36 and 48 hour postoperatively.
The probability of developing chronic neuropathic pain
大体时间:after one month and after two months postoperatively
postoperative examination in pain clinic using LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) scale
after one month and after two months postoperatively

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:Shereen M Mohamed, MD、Lecturer of anesthesia, ICU and pain management- South Egypt Cancer Institute- Assuit University

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。

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

2015年1月1日

初级完成 (实际的)

2015年8月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2015年5月28日

首先提交符合 QC 标准的

2015年6月2日

首次发布 (估计)

2015年6月4日

研究记录更新

最后更新发布 (估计)

2015年12月30日

上次提交的符合 QC 标准的更新

2015年12月29日

最后验证

2015年12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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