Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Intrathecal Injection of Pethidine and Dexamethasone Versus Intrathecal Injection of Bupivacaine in Lower Extremity Orthopedic Surgeries: Comparative Study

ID
Name
8035-7-11-2021
Description
Bupivacaine is commonly used as a sole agent for spinal anesthesia unlike pethidine. Pethidine (meperidine) is a unique opioid. In addition to its analgesic activity, it also has significant local anesthetic activity. This property enables it to be used as the sole agent for spinal anesthesia
Trial arms
Trial start
2021-01-15
Estimated PCD
2024-11-15
Trial end
2024-12-15
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Bupivacaine Hydrochloride
intrathecal injection of bupivacaine alone
Arms:
Bupivacaine group
Other names:
Heavy marcaine
Pethidine plus Dexamethasone
Intrathecal injection of pethidine plus dexamethasone
Arms:
pethidine plus dexamethasone group
Other names:
meperidine and decadron
Size
46
Primary endpoint
changes in the blood pressure measurements
duration of the procedure
changes in the heart rate measurements
duration of the procedure
Level of sensory block
duration of the procedure
Level of motor block
duration of the procedure
Amount of sedative medications needed
duration of the procedure
intraoperative complication
duration of the procedure
Eligibility criteria
Inclusion Criteria: * Patient acceptance. * Patients scheduled for lower extremity orthopedic surgery * Both sex * Patient's age \>18 years. * Patients with American Society of Anaesthesia (ASA)physical status I, II. Exclusion Criteria: * Patient's age ≤18 years. * Uncooperative patients and patients with psychological problems. * Patients with contraindications to spinal anesthesia. * Patients with contraindications to bupivacaine or dexamethasone or pethidine. * Patients with ASA physical status III and IV. * Morbid obesity (BMI \>35).
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 46, 'type': 'ACTUAL'}}
Updated at
2024-02-29

1 organization

2 products

1 indication

Organization
Zagazig University
Product
Bupivacaine
Indication
Postoperative Pain
Product
Pethidine + Dexamethasone