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Clinical trial

Epidural Oxycodone for Pain Management for Lower Limb Amputation: A Randomized Controlled Trial

ID
Name
KFSIRB200-97
Description
The aim of this study is to evaluate the effect of epidural oxycodone for pain management after lower limb amputation.
Trial arms
Trial start
2024-02-24
Estimated PCD
2024-08-01
Trial end
2024-08-01
Status
Recruiting
Treatment
Oxycodone
Patient will receive a bolus dose of 0.15 mg/kg plus 20 ml bupivacaine 0.25% followed by an infusion 0.03 mg/kg/h oxycodone plus 0.1 mL/Kg/h bupivacaine 0.125%.
Arms:
Oxycodone (study group)
Bupivacaine
Patient will receive a bolus 20 ml bupivacaine 0.25% followed by an infusion 0.1 mL/Kg/h bupivacaine 0.125%.
Arms:
Bupivacaine (control group)
Size
40
Primary endpoint
Acute postoperative pain scores
48 hours postoperatively
Eligibility criteria
Inclusion Criteria: * Age 18 to 65 years. * Both sexes. * American Society of Anesthesiologists (ASA) physical status II or III. * Undergoing lower limb amputation. * Under epidural anesthesia. Exclusion Criteria: * Hypersensitivity to opioids. * Cardiac arrhythmias. * Acute asthma or other obstructive airways disease. * Severe renal impairment. * Pregnancy.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ESTIMATED'}}
Updated at
2024-02-28

1 organization

2 products

4 indications

Organization
Kafrelsheikh University
Product
Oxycodone
Indication
Epidural
Indication
Oxycodone
Indication
Pain
Indication
Lower Limb Amputation
Product
Bupivacaine