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临床试验/NCT02462577
NCT02462577已完成2 期

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

Assiut University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
120
试验地点
1
主要终点
changes in acute pain intensity from the baseline

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

local instillation of morphine 5 mg

Active Comparator

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.

干预措施: local instillation of morphine to surgical wound (Drug)

local instillation of morphine 10 mg

Active Comparator

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.

干预措施: local instillation of morphine to surgical wound (Drug)

local instillation of morphine 15 mg

Active Comparator

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.

干预措施: local instillation of morphine to surgical wound (Drug)

local instillation of local anesthetics

Placebo Comparator

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.

干预措施: local instillation of morphine to surgical wound (Drug)

结局指标

主要结局

changes in acute pain intensity from the baseline

时间窗: 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).

次要结局

  • The probability of developing chronic neuropathic pain(after one month and after two months postoperatively)
  • Postoperative adverse effects(2,4,6,12,24,36 and 48 hour postoperatively.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shereen Mamdouh

lecturer of anesthesia,ICU and pain relief

Assiut University

研究点 (1)

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