Regional Anesthesia in Pediatric Orthopaedic Patients
Single-Shot Versus Continuous Regional Anesthesia for Treating Acute Postoperative Pain in Pediatric Orthopaedic Surgery: A Prospective Randomized Trial
1 other identifier
interventional
24
1 country
1
Brief Summary
To identify the benefits from regional anesthesia use as pain management in the pediatric population by delineating the differences in efficacy of continuous nerve blockade versus single-shot techniques after pediatric orthopaedic limb procedures. By doing this, the investigators can determine if specific anesthetic techniques should become a standard of care in pain management for the pediatric population and supersede the need for opioid medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Jun 2021
Typical duration for phase_2
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
December 6, 2020
CompletedFirst Posted
Study publicly available on registry
December 16, 2020
CompletedStudy Start
First participant enrolled
June 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 22, 2024
CompletedJuly 29, 2025
July 1, 2025
2.8 years
December 6, 2020
July 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Opioid Consumption
Amount of opioid medications taken for pain control.
For first 48 hours post-operatively.
Secondary Outcomes (20)
Opioid Consumption
Through 12 hours post-operatively.
Opioid Consumption
Through 24 hours post-operatively.
Opioid Consumption
Through 36 hours post-operatively.
Opioid Consumption
Through 48 hours week post-operatively.
Opioid Consumption
Through 72 hours post-operatively.
- +15 more secondary outcomes
Study Arms (4)
Continuous Regional Anesthesia Lower Limb Surgery
EXPERIMENTALVarious types of regional anesthesia blocks will be performed based on the patient's injuries including fascia iliaca plane blocks, femoral nerve blocks, adductor canal blocks, popliteal approach sciatic nerve blocks, and saphenous nerve blocks A catheter will be placed for the given block for 48 hours. Those patients undergoing lower limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.
Single Shot Regional Anesthesia Lower Limb Surgery
EXPERIMENTALVarious types of regional anesthesia blocks will be performed based on the patient's injuries including fascia iliaca plane blocks, femoral nerve blocks, adductor canal blocks, popliteal approach sciatic nerve blocks, and saphenous nerve blocks. These blocks will be given via a single dose or "single shot". Those patients undergoing lower limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.
Continuous Regional Anesthesia Upper Limb Surgery
EXPERIMENTALVarious types of regional anesthesia blocks involving the brachial plexus will be performed based on the patient's injuries. A catheter will be placed for the given block for 48 hours. Those patients undergoing upper limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.
Single Shot Regional Anesthesia Upper Limb Surgery
EXPERIMENTALVarious types of regional anesthesia blocks involving the brachial plexus will be performed based on the patient's injuries. A catheter will be placed for the given block for 48 hours. Those patients undergoing upper limb orthopaedic surgery will be randomized into single shot or continuous (catheter) regional anesthesia.
Interventions
Dosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study.
Eligibility Criteria
You may qualify if:
- Patients undergoing primary orthopaedic limb surgery
- Outpatient orthopaedic surgeries
- Patients undergoing orthopaedic surgery who would normally receive regional anesthesia
You may not qualify if:
- Patients younger than 5 years of ago or older than 18 years of age
- Revision orthopaedic surgeries
- Spinal orthopaedic surgeries
- Orthopaedic surgeries where the standard of care for type of regional anesthesia has been established (continuous regional for ACL reconstruction)
- Patients with the inability to articulate pain scores
- Inpatient orthopaedic surgeries
- Patients undergoing orthopaedic limb surgery with risk of compartment syndrome (i.e. acute supracondylar humerus fractures)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ochsner Medical Center
Jefferson, Louisiana, 70121, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2020
First Posted
December 16, 2020
Study Start
June 24, 2021
Primary Completion
April 22, 2024
Study Completion
April 22, 2024
Last Updated
July 29, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share