Comparison Between Dexamethasone and Morphine as an Adjuvant to Bupivacaine for Post-operative Analgesia
Condition: Lower Extremities Fracture
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Dexamethasone 8 mg; Morphine 2 mg
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone 8 mg was given via epidural catheter as an adjuvant to 12.5 mg of 0.125% bupivacaine in 10 cc syringe and added with 0.9% sodium chloride until the volume was 10 cc.; Morphine 2 mg was given via epidural catheter as an adjuvant to 12.5 mg of 0.125% bupivacaine in 10 cc syringe and added with 0.9% sodium chloride until the volume was 10 cc.
Other intervention name(s): 0.9 % sodium chloride, 12.5 mg of 0.125% bupivacaine; 0.9% sodium chloride, 12.5 mg of 0.125% bupivacaine
Intervention MeSH terms: Dexamethasone; Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Bupivacaine; adjuvant; regional anesthesia; dexamethasone; morphine