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Clinical trial

A Randomized Comparative Study on the Effect of Using Intrathecal Hyperbaric Prilocaine Plus Fentanyl Compared to Hyperbaric Bupivacaine Plus Fentanyl on the Motor Block in Women Undergoing Caesarean Section Under Spinal Anesthesia

ID
Name
MS-268-2023
Description
To compare the effects of using intrathecal prilocaine combined with fentanyl on duration of motor block versus that of intrathecal bupivacaine combined with fentanyl in elective caesarean section.
Trial arms
Trial start
2023-12-01
Estimated PCD
2024-02-01
Trial end
2024-02-01
Status
Completed
Phase
Early phase I
Treatment
prilocaine
intrathecal 50 mg (2.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).
Arms:
prilocaine
bupivacaine
intrathecal 10 mg (2 ml) of bupivacaine 5% (sunnypivacaine hyperbaric bupivacaine 20 mg/4ml + 25 ug fentanyl (0.5 ml
Arms:
bupivacaine
Size
40
Primary endpoint
time to motor block
time from intrathecal drug injection and time to unassisted ambulation or Bromage's score = 0 (no motor block) (from3 to 5 minutes).
Eligibility criteria
Inclusion Criteria: * Age (18-35) * ASA II * Singleton, full term pregnant females. * Height (1.60-1.90) m. * BMI \> 35 kg m-2 * Scheduled for elective caesarean section under spinal anesthesia. Exclusion Criteria: * Patients requiring general anaesthesia * Known or suspected coagulopathy (international normalised ratio \> 1.4), thrombocytopenia (platelet count \< 100,000). * Known peripheral neuropathy, neurological deficits or skeletal deformities. * Known allergy to prilocaine, bupivacaine , fentanyl. * Infection at site of injection. * Patients' refusal to sign informed consent * Patients with uncontrolled cardiac morbidities (patients with tight valvular lesion, impaired contractility with ejection fraction less than 50%, heart block and arrhythmias), hypertensive disorders of pregnancy, peripartum bleeding.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 40, 'type': 'ACTUAL'}}
Updated at
2024-02-28

1 organization

2 products

1 indication

Organization
Cairo University
Product
prilocaine
Indication
Spinal for Caesarean Section
Product
bupivacaine