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Clinical trial

Comparing General Anesthesia With Single Injection Peribulbar Block With Articaine 4% vs Lidocaine 2% vs Mepivacaine 3 % for Prevention of Oculocardiac Reflex in Children Undergoing Strabismus Surgery : A Randomized Control Study

ID
Name
RIO2022
Description
To compare the effect of the used local anesthetics in this study on decreasing the incidence of oculocardiac reflex . To evaluate the efficacy of Articaine 4 % , mepivacaine 3% and lidocaine 2% regarding post- operative analgesia.
Trial arms
Trial start
2023-02-12
Estimated PCD
2023-04-18
Trial end
2023-04-18
Status
Recruiting
Treatment
Articaine and Epinephrine Only Product
comparison between its effect with the other two local anesthetic drugs in peribulbar block on oculocardiac reflex intraoperatively and postoperative pain in pediatrics undergoing squint surgeries with general anesthesia
Arms:
For group A
levobupivacaine
comparison between its effect with the other two local anesthetic drugs in peribulbar block on oculocardiac reflex intraoperatively and postoperative pain in pediatrics undergoing squint surgeries with general anesthesia
Arms:
Group L
mepivacaine
comparison between its effect with the other two local anesthetic drugs in peribulbar block on oculocardiac reflex intraoperatively and in peribulbar block on postoperative pain in pediatrics undergoing squint surgeries with general anesthesia
Arms:
Group M
Size
55
Primary endpoint
The incidence of Intraoperative oculocardiac reflex.
intraoperative
Eligibility criteria
Inclusion Criteria: * Patients with ASA I , II. * Age from 7 to 14 years old. * Patients undergoing Strabismus Surgery Exclusion Criteria: * Patients with ASA III ,IV. * Patients with Endophthalmitis , orbital fractures. * Any Congenital or Cardiac anomalies. * Patients with history of allergy to local anesthetics. * Revision Surgeries. * Refusal of the Surgeon. Refusal of the patients' parents
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 55, 'type': 'ESTIMATED'}}
Updated at
2023-03-06

1 organization

3 products

1 indication

Organization
Research Institute of Ophthalmology
Product
Articaine and Epinephrine
Indication
Pediatric Strabismus Surgery
Product
levobupivacaine
Product
mepivacaine