Comparing Postoperative Analgesic Techniques for Umbilical Hernia Repair: A Randomized Trial of Ultrasound Guided Caudal, Erector Spinae, and External Oblique Interfascial Plane Blocks
1 other identifier
interventional
75
1 country
1
Brief Summary
The aim of this study is to evaluate the efficacy of ultrasound guided Erector block versus caudal block versus external oblique intercostal plane block perioperatively
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
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
April 10, 2025
CompletedFirst Submitted
Initial submission to the registry
April 17, 2025
CompletedFirst Posted
Study publicly available on registry
April 29, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 10, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 10, 2025
CompletedApril 29, 2025
April 1, 2025
4 months
April 17, 2025
April 23, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Primary outcome
Faces Legs Activity Cry Consolability tool (FLACC, 0- 10)
15 minute after operation , 30 minutes after operation and 4 h after operation
Secondary Outcomes (1)
Secondary outcome
6 hours
Study Arms (3)
Group E
ACTIVE COMPARATORErector spinae plain block group will receive 0.5 ml/kg of 0.25%bupivacaine bilaterally
Group C
ACTIVE COMPARATORCaudal block group will receive 1 ml/kg of 0.25% bupivacaine.
Group EOI
ACTIVE COMPARATORExternal oblique intercostal block will recive 0.5 ml/kg 0.25 % bupivacaine bilaterally.
Interventions
The correct location of the needle tip in the fascial plane deep to the erector spinae muscle will be confirmed by injecting 0.5-1 ml of saline and observing the fluid lifting the erector spinae muscle off the transverse process while avoiding muscle distension (hydro dissection)
The needle will be advanced at a 20-degree angle with needle tip and length visualization. A pop can be appreciated as the needle passes through the sacrococcygeal ligament. Once the needle will be confirmed to be in the caudal space on the screen, carefully aspirate to confirm absence of CSF or blood.
the needle will be advanced until the tip lay in the plane between the external oblique muscle and intercostal muscles between the sixth and seventh ribs
Eligibility Criteria
You may qualify if:
- pediatric patients of both sexes undergoing elective umblical hernia surgeries aged from 2 year to 7 years belonging to ASA I or II.
You may not qualify if:
- Parents refusal.
- Coagulopathy.
- Allergy to local anesthesia.
- Local infection at the site of injection.
- Neurological anomalies.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tanta Universitylead
Study Sites (1)
Mohamed Zakarea Wfa
Tanta, 0020, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisted professor
Study Record Dates
First Submitted
April 17, 2025
First Posted
April 29, 2025
Study Start
April 10, 2025
Primary Completion
August 10, 2025
Study Completion
September 10, 2025
Last Updated
April 29, 2025
Record last verified: 2025-04