Effect of Prilocaine on Motor Block During Caesarean Section
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
1 other identifier
interventional
40
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Dec 2023
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2023
CompletedFirst Posted
Study publicly available on registry
November 18, 2023
CompletedStudy Start
First participant enrolled
December 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedFebruary 28, 2024
February 1, 2024
2 months
November 2, 2023
February 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Secondary Outcomes (1)
time to sensory block (T4)
time from intrathecal drug injection and complete absence of skin sensation to the pinprick test at T4 (from 1 to 5 minutes)
Study Arms (2)
prilocaine
EXPERIMENTALbupivacaine
ACTIVE COMPARATORInterventions
intrathecal 50 mg (2.5 ml) of prilocaine 2% (Takipril, prilocaine hydrochloride 20 mg/mL, hyperbar, Sintetica) + 25 ug fentanyl (0.5 ml).
intrathecal 10 mg (2 ml) of bupivacaine 5% (sunnypivacaine hyperbaric bupivacaine 20 mg/4ml + 25 ug fentanyl (0.5 ml
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of Medicine Cairo University
Cairo, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- associate professor
Study Record Dates
First Submitted
November 2, 2023
First Posted
November 18, 2023
Study Start
December 1, 2023
Primary Completion
February 1, 2024
Study Completion
February 1, 2024
Last Updated
February 28, 2024
Record last verified: 2024-02