Erector Spinae Muscle Block Versus Caudal Block by Sonar in Pediatrics Undergoing Lower Abdominal Surgery
Ultrasound-guided Erector Spinae Muscle Block Versus Ultrasound-guided Caudal Block in Pediatric Patient Undergoing Lower Abdominal Surgery
1 other identifier
interventional
60
1 country
1
Brief Summary
this prospective randomized double blind controlled study was conducted on 60 child scheduled for lower abdominal surgery under general anesthesia. the patients were randomly allocated into 3 parallel groups.group (ESB) patients received ultrasound-guided erector spinae block in a dose of 0.4mg/ml of 0.25%bupivacaine between the 10th transverse process and erector spinae muscles.group(CB) patients received ultrasound-guided caudal block in a dose of 2.5mg/kg of 0.25%bupivacaine. group(CO) did,t received any block
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2019
Shorter than P25 for not_applicable
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
Study Start
First participant enrolled
July 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2020
CompletedFirst Submitted
Initial submission to the registry
December 28, 2020
CompletedFirst Posted
Study publicly available on registry
December 31, 2020
CompletedMarch 8, 2021
May 1, 2019
6 months
December 28, 2020
March 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
number of patients need rescue analgesia
total number of patients need addition of anagesia
24 hours
Secondary Outcomes (2)
First analgesic request
24 hours
Hemodynamic changes in the study period
24 hours
Study Arms (3)
Erector spinae group
ACTIVE COMPARATORthe child received ultrasound-guided erector spinae muscle block in a dose of 0.4mg/kg of 0.25%bupivacaine between the 10th transverse process and erector spinae muscle
caudal group
ACTIVE COMPARATORchild received ultrasound-guided caudal block in a dose of 2.5mg/kg of bupivacaine 0.25%
control
NO INTERVENTIONchild didn't received any regional block
Interventions
the child placed in lateral position identification of spinous process of 10th thoracic vertebral then the transducer was moved 2.5 cm laterally to visualize the transverse process and a total of 0.4mg/kg of 0.25%bupivacaine was adminstered
Eligibility Criteria
You may qualify if:
- pediatric patients aged 2-6 years scheduled for lower abdominal surgery under general anesthesia
You may not qualify if:
- parent refusal
- spinal and meningeal anomalies
- mental retardation
- blood disease
- infection at site of injection
- drug allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Minia Universitylead
Study Sites (1)
Faculty of Medicine
Minya, 61111, Egypt
Related Publications (1)
Abdelrazik AN, Ibrahim IT, Farghaly AE, Mohamed SR. Ultrasound-guided Erector Spinae Muscle Block Versus Ultrasound-guided Caudal Block in Pediatric Patients Undergoing Lower Abdominal Surgeries. Pain Physician. 2022 Jul;25(4):E571-E580.
PMID: 35793181DERIVED
Study Officials
- STUDY DIRECTOR
Ibrahim Talaat, MD
professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- lecturer
Study Record Dates
First Submitted
December 28, 2020
First Posted
December 31, 2020
Study Start
July 15, 2019
Primary Completion
January 15, 2020
Study Completion
February 15, 2020
Last Updated
March 8, 2021
Record last verified: 2019-05