Clinical trial NCT04669145: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Anesthesia, Local
Anesthesia
Orthopedic Disorder
Lead sponsor: Ochsner Health System
Sponsor class: OTHER
First posted: 2020-12-16
Enrollment: 88
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Opioid Consumption
timeFrame: For first 48 hours post-operatively.
Secondary outcomes:
measure: Opioid Consumption
timeFrame: Through 12 hours post-operatively.
measure: Opioid Consumption
timeFrame: Through 24 hours post-operatively.
measure: Opioid Consumption
timeFrame: Through 36 hours post-operatively.
measure: Opioid Consumption
timeFrame: Through 48 hours week post-operatively.
measure: Opioid Consumption
timeFrame: Through 72 hours post-operatively.
measure: Opioid Consumption
timeFrame: Through 96 hours post-operatively.
measure: Opioid Consumption
timeFrame: Through 120 hours post-operatively.
measure: Opioid Consumption
timeFrame: Through 144 hours post-operatively.
measure: Opioid Consumption
timeFrame: Through 168 hours post-operatively.
measure: Emergency Room Visits
timeFrame: Within 2 weeks post-operatively.
measure: Pain Scores
timeFrame: At 12 hours post-operatively.
measure: Pain Scores
timeFrame: At 24 hours post-operatively.
measure: Pain Scores
timeFrame: At 36 hours post-operatively.
measure: Pain Scores
timeFrame: At 48 hours post-operatively.
measure: Pain Scores
timeFrame: At 72 hours post-operatively.
measure: Pain Scores
timeFrame: At 96 hours post-operatively.
measure: Pain Scores
timeFrame: At 120 hours post-operatively.
measure: Pain Scores
timeFrame: At 144 hours post-operatively.
measure: Pain Scores
timeFrame: At 168 hours post-operatively.
measure: Pain Scores
timeFrame: At 2 weeks post-operatively.
Other outcomes:
Locations:
city: Jefferson
country: United States
facility: Ochsner Medical Center
state: Louisiana
Study officials:
References: