Back to resultsRegional Anesthesia in Pediatric Orthopaedic Patients
Primary Purpose
Anesthesia, Local, Anesthesia, Orthopedic Disorder
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Sponsored by
About this trial
This is an interventional treatment trial for Anesthesia, Local
Eligibility Criteria
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)
Sites / Locations
- Ochsner Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Continuous Regional Anesthesia Lower Limb Surgery
Single Shot Regional Anesthesia Lower Limb Surgery
Continuous Regional Anesthesia Upper Limb Surgery
Single Shot Regional Anesthesia Upper Limb Surgery
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
Opioid Consumption
Amount of opioid medications taken for pain control.
Secondary Outcome Measures
Opioid Consumption
Amount of opioid medications taken for pain control.
Opioid Consumption
Amount of opioid medications taken for pain control.
Opioid Consumption
Amount of opioid medications taken for pain control.
Opioid Consumption
Amount of opioid medications taken for pain control.
Opioid Consumption
Amount of opioid medications taken for pain control.
Opioid Consumption
Amount of opioid medications taken for pain control.
Opioid Consumption
Amount of opioid medications taken for pain control.
Opioid Consumption
Amount of opioid medications taken for pain control.
Opioid Consumption
Amount of opioid medications taken for pain control.
Emergency Room Visits
Emergency room visits due to poor pain control.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04669145
Brief Title
Regional Anesthesia in Pediatric Orthopaedic Patients
Official Title
Single-Shot Versus Continuous Regional Anesthesia for Treating Acute Postoperative Pain in Pediatric Orthopaedic Surgery: A Prospective Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2021 (Actual)
Primary Completion Date
May 28, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ochsner Health System
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Local, Anesthesia, Orthopedic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Continuous Regional Anesthesia Lower Limb Surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
Single Shot Regional Anesthesia Lower Limb Surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
Continuous Regional Anesthesia Upper Limb Surgery
Arm Type
Experimental
Arm Description
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.
Arm Title
Single Shot Regional Anesthesia Upper Limb Surgery
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Intervention Description
Dosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study.
Primary Outcome Measure Information:
Title
Opioid Consumption
Description
Amount of opioid medications taken for pain control.
Time Frame
For first 48 hours post-operatively.
Secondary Outcome Measure Information:
Title
Opioid Consumption
Description
Amount of opioid medications taken for pain control.
Time Frame
Through 12 hours post-operatively.
Title
Opioid Consumption
Description
Amount of opioid medications taken for pain control.
Time Frame
Through 24 hours post-operatively.
Title
Opioid Consumption
Description
Amount of opioid medications taken for pain control.
Time Frame
Through 36 hours post-operatively.
Title
Opioid Consumption
Description
Amount of opioid medications taken for pain control.
Time Frame
Through 48 hours week post-operatively.
Title
Opioid Consumption
Description
Amount of opioid medications taken for pain control.
Time Frame
Through 72 hours post-operatively.
Title
Opioid Consumption
Description
Amount of opioid medications taken for pain control.
Time Frame
Through 96 hours post-operatively.
Title
Opioid Consumption
Description
Amount of opioid medications taken for pain control.
Time Frame
Through 120 hours post-operatively.
Title
Opioid Consumption
Description
Amount of opioid medications taken for pain control.
Time Frame
Through 144 hours post-operatively.
Title
Opioid Consumption
Description
Amount of opioid medications taken for pain control.
Time Frame
Through 168 hours post-operatively.
Title
Emergency Room Visits
Description
Emergency room visits due to poor pain control.
Time Frame
Within 2 weeks post-operatively.
Title
Pain Scores
Description
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.
Time Frame
At 12 hours post-operatively.
Title
Pain Scores
Description
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.
Time Frame
At 24 hours post-operatively.
Title
Pain Scores
Description
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.
Time Frame
At 36 hours post-operatively.
Title
Pain Scores
Description
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.
Time Frame
At 48 hours post-operatively.
Title
Pain Scores
Description
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.
Time Frame
At 72 hours post-operatively.
Title
Pain Scores
Description
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.
Time Frame
At 96 hours post-operatively.
Title
Pain Scores
Description
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.
Time Frame
At 120 hours post-operatively.
Title
Pain Scores
Description
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.
Time Frame
At 144 hours post-operatively.
Title
Pain Scores
Description
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.
Time Frame
At 168 hours post-operatively.
Title
Pain Scores
Description
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.
Time Frame
At 2 weeks post-operatively.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Ochsner Medical Center
City
Jefferson
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brielle Plost, MD
Phone
504-842-3970
Email
brielle.plost@ochsner.org
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Regional Anesthesia in Pediatric Orthopaedic Patients
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