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

University of Indonesia (UI)

Status

Completed

Conditions

Lower Extremities Fracture

Treatments

Drug: Morphine 2 mg

Drug: Dexamethasone 8 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT03051022

IndonesiaUAnes008

Details and patient eligibility

About

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.

Full 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.

Enrollment

64 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.