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临床试验/NCT02685475
NCT02685475已完成不适用

Comparison of Ultrasound-Guided Axillary Brachial Plexus Block Properties in Diabetic and Non-diabetic Patients: A Prospective Observational Study

Istanbul University1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
71
试验地点
1
主要终点
Sensory block duration

研究概览

简要总结

Background and objectives: The investigators performed this study to explore whether the presence of diabetes mellitus (DM) would affect the outcomes of axillary brachial plexus blocks (ABPBs) in patients undergoing elective forearm and/or hand surgery. The primary hypothesis was that the sensory block duration would be delayed in diabetic patients.

Methods: After obtaining ethics committee approval and written informed consent, 71 patients were enrolled to the study. Diabetic patients were included in Group DM and non-diabetics were included in Group NODM. All received ultrasound-guided ABPBs with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%. Our primary outcome was sensory block duration, and secondary outcomes were sensory and motor block onset times, motor block duration, time-to-first-pain (numeric rating scale (NRS) ≥4), postoperative NRS scores and rescue analgesic consumption (NRS) ≥4) through the postoperative first 2 days. All outcomes were assessed by a blinded investigators.

详细描述

Background and objectives: The impact of diabetes mellitus (DM) on the practice of peripheral nerve block anesthesia was mostly investigated in animal researches, and effects on human models are required to be clarified. The investigators performed this study to explore whether the presence of DM would affect the outcomes of axillary brachial plexus blocks (ABPBs) in patients undergoing elective forearm and/or hand surgery. The primary hypothesis was that the sensory block duration would be delayed in diabetic patients.

Methods: After obtaining ethics committee approval and written informed consent, 71 patients with American Society of Anesthesiologists (ASA) physical status I-III and aged between 40 and 75 years were enrolled to the study. Diabetic patients were included in Group DM and non-diabetics were included in Group NODM. All received ultrasound-guided ABPBs with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%. Postoperatively, patients were administered paracetamol as rescue analgesics, if numeric rating scale (NRS) was ≥4. Our primary outcome was sensory block duration, and secondary outcomes were sensory and motor block onset times, motor block duration, time-to-first-pain (numeric rating scale (NRS) ≥4), postoperative NRS scores, and rescue analgesic consumption (NRS) ≥4) through the postoperative first 2 days. All outcomes were assessed by a blinded investigators.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for elective forearm and/or hand surgery American Society of Anesthesiologists (ASA) physical status I-III No regional anesthesia contraindication

排除标准

  • Type 1 DM Type 2 DM patients with only 'diet-controlled' therapy Difficulty with understanding the block and follow-up instructions Significant neurologic disorders Psychiatric or cognitive disorders History of substance abuse Acute and/or chronic opioid use Local anaesthetic hypersensitivity or allergy

研究组 & 干预措施

Diabetic patients

Patients received ultrasound-guided axillary brachial plexus blocks (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%.

干预措施: Axillary Brachial Plexus Blocks (Drug)

Non-diabetic patients

Patients received ultrasound-guided axillary brachial plexus blocks (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%.

干预措施: Axillary Brachial Plexus Blocks (Drug)

结局指标

主要结局

Sensory block duration

时间窗: 0-24 hours

Time interval between a successful block and the complete restoration of all the senses controlled by the radial, ulnar, median and musculocutaneous nerves.

次要结局

  • Sensory block onset time(0-30 minutes)
  • Motor block onset time(0-30 minutes)
  • Motor block duration(0-24 hours)
  • Time-to-first pain(0-48 hours)
  • Pain (NRS) scores(0-48 hours)
  • Rescue analgesic consumption(0-48 hours)

研究者

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

Emine Aysu Salviz, MD

M.D., Attending Anesthesiologist

Istanbul University

研究点 (1)

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