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临床试验/NCT02620371
NCT02620371已完成3 期

Efficacy and Safety of Ketamine Added to Local Anesthetic in Modified Pectoral Block for Management of Postoperative Pain in Patients Undergoing Modified Radical Mastectomy

Assiut University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年9月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
2
主要终点
Total morphine consumption

研究概览

简要总结

This study aims to compare the analgesic efficacy and safety of local bupivacaine alone versus bupivacaine plus ketamine in ultrasound guided modified Pecs block in patients undergoing breast cancer surgery.

详细描述

This randomized Clinical trial was approved by the ethics committee of South Egypt Cancer Institute, Assuit University, Assuit, Egypt. Sixty patients aged 18 - 60 years, American Society of Anesthesiologists (ASA) class I-II, with body weight of 50 - 90 kg and arranged for modified radical mastectomy) were enrolled in this study. Patients with a history of bleeding diathesis, relevant drug allergy, opioid dependence, morbid obesity, sepsis, prior surgery in the supraclavicular, infraclavicular or axillary regions, alcohol or drug abuse and those with psychiatric illnesses that would interfere with perception and assessment of pain were excluded from the study.

Preoperatively, patients were taught how to evaluate their own pain intensity using the Visual Analog Scale (VAS), scored from 0-10 (where 0= no pain and 10=worst pain imaginable), and whenever (during the follow up period) VAS points to a value ≥ 3. Analgesia comprised PCA with an initial morphine bolus of 0.1mg/kg once pain expressed by the patient or if VAS ≥ 3 followed by 1mg boluses with a lockout period a 5 minute. The time to first request for analgesia and the total analgesic consumption in the first 24 hours were recorded.

On arrival to the operating room, an intravenous line was inserted. Monitoring included electrocardiography (ECG), non-invasive blood pressure (NIBP), arterial oxygen saturation (Sao2) and end-tidal carbon- dioxide were applied.

Anesthesia was induced for all participating patients with 2 μg/kg fentanyl, 2-3 mg/kg propofol and 1.5 mg/kg lidocaine. Endotracheal intubation was facilitated by 0.15 mg/kg cis-atracurium. Anesthesia was maintained by 1-1.5 MAC isoflurane in 50% oxygen / air mixture and 0.03 mg/kg cisatrcurium respectively in ventilation parameters to maintain on ETco2 of approximately 35- 40 mmHg. Ultrasound guided pecs block then performed

Patients were randomly assigned into 2 groups (using a randomization-computer program), 30 patients in each:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Double (Participant, Investigator)

入排标准

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

入选标准

  • American Society of Anesthesiologists (ASA) class I-II
  • Body weight of 50 - 90 kg

排除标准

  • History of bleeding diathesis
  • Relevant drug allergy, opioid dependence
  • Morbid obesity, sepsis
  • prior surgery in the supraclavicular, infraclavicular or axillary regions,
  • Alcohol or drug abuse
  • Those with psychiatric illnesses that would interfere with perception and assessment of pain

结局指标

主要结局

Total morphine consumption

时间窗: first 48 hours postoperatively

Total morphine consumption in mg in the first 48 hours postoperatively

次要结局

  • first request of rescue analgesia(48 hours postoperatively)
  • the severity of pain was assessed using VAS score(48 hours postoperatively)

研究者

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

Fatma Adel El sherif

principal investigator

Assiut University

研究点 (2)

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