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临床试验/NCT03051022
NCT03051022已完成不适用

The Comparison Between Dexamethasone and Morphine as an Adjuvant to Epidural Bupivacaine for Post-operative Analgesia in Lower Extremity Surgery

Indonesia University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2016年5月1日最近更新:
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
64
试验地点
1
主要终点
The time for first requested post-operative additional analgesia

研究概览

简要总结

The study aimed to compare the effectivity of dexamethasone 8 mg and morphine 2 mg as an adjuvant to epidural bupivacaine 0,125% 12,5mg for post-operative analgesia in lower extremities.

详细描述

Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study and randomized into two groups. Intravenous (IV) cannula with Ringer Lactate fluid, non-invasive blood pressure monitor, electrocardiogram (ECG) and pulse-oxymetry were set on the subjects in the operation room. Epidural catheter was inserted (4 cm depth inside the epidural space) with 1,5-2 mg IV midazolam and 50 mcg IV fentanyl as premedication. The catheter insertion was confirmed with vacuum aspiration and negative test-dose. General anesthesia induction was done by fentanyl 2 mcg/kg, propofol 2 mg/kg, and atracurium 0,5 mg/kg. Maintenance was done by sevoflurane 2vol%, fentanyl and atracurium. Surgery starts without intraoperative epidural regimen. Surgery duration, blood pressure, heart rate, respiratory rate, oxygen saturation by pulse oximetry (SpO2) were recorded. For post-operative analgesia, subjects received paracetamol 1 gr IV and intermittent epidural analgesia regimen in a 10 cc syringe: Group 1 received Bupivacaine 0,125% 12,5 mg combined with dexamethasone 8 mg plus 0,9% sodium chloride (NaCl) until the volume was 10 cc; Group 2 received Bupivacaine 0,125% 12,5 mg combined with morphine 2 mg plus 0,9% NaCl until the volume was 10 cc. The injection was given by anesthesiology residents without knowing the syringe's content. Patient Controlled Analgesia (PCA) morphine was given in the recovery room. Data recorded were blood pressure, heart rate, respiratory rate, oxygen saturation, visual analog scale, side effects, the time when first additional analgesia was needed by subjects, the opioid requirement within 24 hours post-operation. Data was analyzed using Statistical Package for the Social Sciences (SPSS) software, for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square or Fisher Exact Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p<0.05.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Subjects aged 18-60 years old with American Society of Anesthesiologists (ASA) physical status I-II and body mass index (BMI) 18,5-25 kg/m2 who were planned to undergo lower extremity surgery
  • Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form

排除标准

  • Subjects with history of bupivacaine allergy
  • Subjects with history of morphine allergy
  • Subjects with history of urine retention
  • Subjects with history of gait disturbance or using prosthetic, Subjects with history of peptic ulcer
  • Subjects with history of long term use of corticosteroid
  • Subjects with contraindications for epidural anesthesia
  • Subjects rejected to participate in the study.
  • Drop out criteria:
  • Subjects with epidural anesthesia complications (e.g. shock, anaphylactic reaction, seizures, severe respiratory disturbance)
  • Subjects with failed epidural anesthesia.

研究组 & 干预措施

Dexamethasone 8 mg

Active Comparator

Bupivacaine 0,125% 12,5 mg combined with dexamethasone 8 mg plus NaCl 0,9% until the volume was 10 cc, prepared in a 10 cc syringe.

干预措施: Dexamethasone 8 mg (Drug)

Morphine 2 mg

Active Comparator

Bupivacaine 0,125% 12,5 mg combined with morphine 2 mg plus NaCl 0,9% until the volume was 10 cc, prepared in a 10 cc syringe.

干预措施: Morphine 2 mg (Drug)

结局指标

主要结局

The time for first requested post-operative additional analgesia

时间窗: 24 hours post-operative

How long (in minutes) until the subject requested for an additional analgesics after surgery.

The degree of pain at 24-hours post-operative

时间窗: 24 hours post-operative

The degree of pain was measured using Visual Analog Scale (VAS)

The opioid requirement with the first 24-hours post-operative

时间窗: 24-hours post-operative

Patient Controlled Analgesia (PCA) measured the opioid requirement in milligram.

次要结局

  • Side Effects(24-hours post-operative)

研究者

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

Dr. dr. Aida Rosita Tantri SpAn-KA

Consultant, Anesthesiologist

Indonesia University

研究点 (1)

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