Regional Anesthesia in Pediatric Orthopaedic Patients

Study Overview
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Brief Summary
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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.

Official Title
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Single-Shot Versus Continuous Regional Anesthesia for Treating Acute Postoperative Pain in Pediatric Orthopaedic Surgery: A Prospective Randomized Trial

Conditions
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Anesthesia, Local, Anesthesia, Orthopedic Disorder

Intervention / Treatment
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* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing primary orthopaedic limb surgery Outpatient orthopaedic surgeries Patients undergoing orthopaedic surgery who would normally receive regional anesthesia Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Continuous Regional Anesthesia Lower Limb Surgery<br>Various 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. | Drug: Ropivacaine<br>* Dosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study.<br>|
| Experimental: Single Shot Regional Anesthesia Lower Limb Surgery<br>Various 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. | Drug: Ropivacaine<br>* Dosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study.<br>|
| Experimental: Continuous Regional Anesthesia Upper Limb Surgery<br>Various 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. | Drug: Ropivacaine<br>* Dosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study.<br>|
| Experimental: Single Shot Regional Anesthesia Upper Limb Surgery<br>Various 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. | Drug: Ropivacaine<br>* Dosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Amount of opioid medications taken for pain control. | For first 48 hours post-operatively. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Consumption | Amount of opioid medications taken for pain control. | Through 12 hours post-operatively. | 
| Opioid Consumption | Amount of opioid medications taken for pain control. | Through 24 hours post-operatively. | 
| Opioid Consumption | Amount of opioid medications taken for pain control. | Through 36 hours post-operatively. | 
| Opioid Consumption | Amount of opioid medications taken for pain control. | Through 48 hours week post-operatively. | 
| Opioid Consumption | Amount of opioid medications taken for pain control. | Through 72 hours post-operatively. | 
| Opioid Consumption | Amount of opioid medications taken for pain control. | Through 96 hours post-operatively. | 
| Opioid Consumption | Amount of opioid medications taken for pain control. | Through 120 hours post-operatively. | 
| Opioid Consumption | Amount of opioid medications taken for pain control. | Through 144 hours post-operatively. | 
| Opioid Consumption | Amount of opioid medications taken for pain control. | Through 168 hours post-operatively. | 
| Emergency Room Visits | Emergency room visits due to poor pain control. | Within 2 weeks post-operatively. | 
| Pain Scores | Universal Pain Assessment tool will be used. The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain. | At 12 hours post-operatively. | 
| Pain Scores | Universal Pain Assessment tool will be used. The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain. | At 24 hours post-operatively. | 
| Pain Scores | Universal Pain Assessment tool will be used. The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain. | At 36 hours post-operatively. | 
| Pain Scores | Universal Pain Assessment tool will be used. The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain. | At 48 hours post-operatively. | 
| Pain Scores | Universal Pain Assessment tool will be used.The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain. | At 72 hours post-operatively. | 
| Pain Scores | Universal Pain Assessment tool will be used.The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain. | At 96 hours post-operatively. | 
| Pain Scores | Universal Pain Assessment tool will be used.The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain. | At 120 hours post-operatively. | 
| Pain Scores | Universal Pain Assessment tool will be used.The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain. | At 144 hours post-operatively. | 
| Pain Scores | Universal Pain Assessment tool will be used.The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain. | At 168 hours post-operatively. | 
| Pain Scores | Universal Pain Assessment tool will be used. The pain scale ranges from 0 to 10 with 0 being no pain and 10 being the worst possible pain. | At 2 weeks post-operatively. |