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

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

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

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

More Information

Publications:

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• Responsible Party: Dr. dr. Aida Rosita Tantri SpAn-KA, Consultant, Anesthesiologist, Indonesia University
• ClinicalTrials.gov Identifier: NCT03051022
• Other Study ID Numbers: IndonesiaUAnes008
• First Posted: February 13, 2017
• 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; Morphine; Bupivacaine; 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; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics, Opioid; Narcotics; Analgesics