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

August 15, 2017 updated by: Dr. dr. Aida Rosita Tantri SpAn-KA, Indonesia University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
    • DKI Jakarta
      • Central Jakarta, DKI Jakarta, Indonesia, 10430
        • Cipto Mangunkusumo hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 0.9% sodium chloride, 12.5 mg of 0.125% bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
24 hours post-operative
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.
24 hours post-operative
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.
24-hours post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Side Effects
Time Frame: 24-hours post-operative
Side effects measured were incidences of nausea/vomiting, motoric inhibition, sedation, respiratory depression, hypotension
24-hours post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Investigators

  • Principal Investigator: Aida R Tantri, PhD, Indonesia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2016

Primary Completion (ACTUAL)

November 30, 2016

Study Completion (ACTUAL)

March 31, 2017

Study Registration Dates

First Submitted

February 5, 2017

First Submitted That Met QC Criteria

February 8, 2017

First Posted (ACTUAL)

February 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 18, 2017

Last Update Submitted That Met QC Criteria

August 15, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IndonesiaUAnes008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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