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

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ClinicalTrials.gov Identifier: NCT03051022
Recruitment Status : Completed
First Posted : February 13, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. dr. Aida Rosita Tantri SpAn-KA, Indonesia University

Brief 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.

Condition or disease Intervention/treatment Phase
Lower Extremities Fracture Drug: Dexamethasone 8 mg Drug: Morphine 2 mg Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Comparison Between Dexamethasone and Morphine as an Adjuvant to Epidural Bupivacaine for Post-operative Analgesia in Lower Extremity Surgery
Actual Study Start Date : May 1, 2016
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : March 31, 2017


Arm Intervention/treatment
Active Comparator: Dexamethasone 8 mg
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.
Drug: Dexamethasone 8 mg
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 Name: 0.9 % sodium chloride, 12.5 mg of 0.125% bupivacaine

Active Comparator: Morphine 2 mg
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.
Drug: Morphine 2 mg
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 Name: 0.9% sodium chloride, 12.5 mg of 0.125% bupivacaine




Primary Outcome Measures :
  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 Outcome Measures :
  1. Side Effects [ Time Frame: 24-hours post-operative ]
    Side effects measured were incidences of nausea/vomiting, motoric inhibition, sedation, respiratory depression, hypotension



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03051022


Locations
Indonesia
Cipto Mangunkusumo Hospital
Central Jakarta, DKI Jakarta, Indonesia, 10430
Sponsors and Collaborators
Indonesia University
Investigators
Principal Investigator: Aida R Tantri, PhD Indonesia University

Publications:

Responsible Party: Dr. dr. Aida Rosita Tantri SpAn-KA, Consultant, Anesthesiologist, Indonesia University
ClinicalTrials.gov Identifier: NCT03051022     History of Changes
Other Study ID Numbers: IndonesiaUAnes008
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Dr. dr. Aida Rosita Tantri SpAn-KA, Indonesia University:
Bupivacaine
adjuvant
regional anesthesia
dexamethasone
morphine

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Bupivacaine
Morphine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Analgesics, Opioid
Narcotics
Analgesics