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临床试验/NCT02462681
NCT02462681已完成1 期

Ketamine as Adjunctive Analgesic With Bupivacaine in Paravertebral Analgesia for Breast Cancer Surgery

Assiut University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
90
试验地点
1
主要终点
changes in pain intensity score from baseline

研究概览

简要总结

This study aims to investigate the safety and the analgesic efficacy of adding Ketamine to bupivacaine 0.25% in thoracic PVB in patients undergoing modified radical mastectomy.

详细描述

Breast cancer is perhaps the most common cancer in women that requires frequent surgical intervention. Nearly 40% of post-operative breast surgery patients experience significant acute post-operative pain, with a pain score above five reflecting inadequacy of conventional pain management. Most of the responses of the human body to post-surgical pain have been proven to be detrimental to the patient's homeostasis and recovery. Moreover, the incidence of chronic postoperative pain in breast surgery patients is as high as 50% and inadequate analgesia is considered as an independent risk factor. Hence, a number of therapeutic measures have been accepted as a part of the "multi-modal" approach to post-operative pain control. Thoracic Paravertebral Block (PVB) is used for pain relief after thoracotomy , and mastectomy. PVB can provide profound, long lasting sensory differentiation. The resulting greater attenuation of surgical stress response may translate into reduced inotropic stimulation of the heart. Additionally, unlike general anesthesia, PVB can provide superior postoperative analgesia, less nausea and vomiting, shorter recovery time; require fewer analgesic, earlier mobilization, and earlier home readiness for discharge. The use of PVB in patients undergoing ambulatory breast surgery has cost-saving potential. There is little systematic research on the efficacy and tolerability of the addition of adjunctive analgesic agent in paravertebral analgesia. The addition of adjunctive analgesics, such as fentanyl and clonidine to local anesthetics has been shown to enhance the quality and duration of sensory neural blockade, and decrease the dose of local anesthetic and supplemental analgesia .

Ketamine is an anaesthetic agent with potent analgesic properties. Its mode of action includes noncompetitive antagonism at N-methyl d-aspartate (NMDA) receptors and a local anaesthetic effect. ketamine has been extensively used through epidural and caudal routes with variable results.It possesses some definite advantages over the conventional local anaesthetic agents as it stimulates cardiovascular system and respiratory system.The advantages of ketamine include a good analgesic effect, cardio vascular stability in a hypotensive state, bronchodilatation in asthmatics, and the absence of awareness. Disadvantages include increased heart rate and blood pressure, emergence phenomenon, laryngospasm and apnea, increases in intracranial and intraocular pressure, and the lack of visceral anesthesia.

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
25 Years 至 70 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • all patients scheduled for elective modified radical mastectomy with axillary dissection will be enrolled in the study

排除标准

  • patients with a known allergy to the study drugs
  • patients with bleeding diathesis
  • patients with infection at the site of injection
  • patients with central neuropathy
  • patients with liver impairment
  • patients with renal impairment
  • drugs or alcohol abusers
  • patients with psychiatric illnesses

研究组 & 干预措施

bupivacaine group in paravertebral block

Active Comparator

patients will be received 20 ml of bupivacaine 0.25% paravertebrally, divided into 3-4 ml in each level

干预措施: paravertebral block (Drug)

bupivacaine + 0.5 mg/kg ketamine group in paravertebral block

Active Comparator

patients will be received 20 ml of bupivacaine 0.25% + 0.5 mg/kg ketamine paravertebrally divide into 3-4 ml in each level

干预措施: paravertebral block (Drug)

bupivacaine + 1 mg/kg ketamine group in paravertebral block

Active Comparator

patients will be received 20 ml of bupivacaine 0.25% + 1mg/kg ketamine paravertebrally divide into 3-4 ml in each level

干预措施: paravertebral block (Drug)

结局指标

主要结局

changes in pain intensity score from baseline

时间窗: at 2,4,6,12,24,36and 48 hour postoperatively

Visual analogue scale (VAS) Scored from 0-10 (where 0= no pain and 10= the worst pain imaginable) as it measured as VAS at rest (VAS.R) and during movement or ipsilateral arm abduction (VAS.M)

次要结局

  • side effect(2,4,6,12,24,36and 48 hour postoperatively.)
  • chronic neuropathic pain(1st,2nd and 3rd postoperative months)

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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