MedPath

Regional Anesthesia in Pediatric Orthopaedic Patients

Phase 2
Recruiting
Conditions
Anesthesia, Local
Anesthesia
Orthopedic Disorder
Interventions
Registration Number
NCT04669145
Lead Sponsor
Ochsner Health System
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
88
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Continuous Regional Anesthesia Lower Limb SurgeryRopivacaineVarious 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 SurgeryRopivacaineVarious 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.
Single Shot Regional Anesthesia Upper Limb SurgeryRopivacaineVarious 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.
Continuous Regional Anesthesia Upper Limb SurgeryRopivacaineVarious 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.
Primary Outcome Measures
NameTimeMethod
Opioid ConsumptionFor first 48 hours post-operatively.

Amount of opioid medications taken for pain control.

Secondary Outcome Measures
NameTimeMethod
Emergency Room VisitsWithin 2 weeks post-operatively.

Emergency room visits due to poor pain control.

Opioid ConsumptionThrough 168 hours post-operatively.

Amount of opioid medications taken for pain control.

Pain ScoresAt 2 weeks post-operatively.

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.

Trial Locations

Locations (1)

Ochsner Medical Center

🇺🇸

Jefferson, Louisiana, United States

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