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
Verified date | August 2017 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Indonesia | Cipto Mangunkusumo Hospital | Central Jakarta | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
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* Note: There are 16 references in all — Click here to view all references
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 |