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

Lower Extremities Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03051022
• Other study ID #: IndonesiaUAnes008
• Status: Completed
• Phase: N/A
• First received: February 5, 2017
• Last updated: August 15, 2017
• Start date: May 1, 2016
• Est. completion date: March 31, 2017

Study information

• Verified date: August 2017
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 31, 2017
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lower Extremities Fracture

Intervention

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.
• 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.

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Central Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (16)

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* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The degree of pain at 24-hours post-operative	The degree of pain was measured using Visual Analog Scale (VAS)	24 hours post-operative
Primary	The time for first requested post-operative additional analgesia	How long (in minutes) until the subject requested for an additional analgesics after surgery.	24 hours post-operative
Primary	The opioid requirement with the first 24-hours post-operative	Patient Controlled Analgesia (PCA) measured the opioid requirement in milligram.	24-hours post-operative
Secondary	Side Effects	Side effects measured were incidences of nausea/vomiting, motoric inhibition, sedation, respiratory depression, hypotension	24-hours post-operative