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Completed

NCT Number: NCT03051022

Comparison Between Dexamethasone and Morphine as an Adjuvant to Bupivacaine for Post-operative Analgesia

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cipto Mangunkusumo Hospital

Central Jakarta, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Dexamethasone 8 mg

Drug

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.

Other names: 0.9 % sodium chloride, 12.5 mg of 0.125% bupivacaine

Morphine 2 mg

Drug

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 names: 0.9% sodium chloride, 12.5 mg of 0.125% bupivacaine

Primary outcomes

  1. The degree of pain at 24-hours post-operative

    Time frame: 24 hours post-operative

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

  2. The time for first requested post-operative additional analgesia

    Time frame: 24 hours post-operative

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

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

    Time frame: 24-hours post-operative

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

Secondary outcomes

  1. Side Effects

    Time frame: 24-hours post-operative

    Side effects measured were incidences of nausea/vomiting, motoric inhibition, sedation, respiratory depression, hypotension

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Feb 13, 2017
Registry last updated
Aug 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.