Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 5 Years and 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2/Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Continuous Regional Anesthesia Lower Limb Surgery
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
    Dosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study.
Experimental
Single Shot Regional Anesthesia Lower Limb Surgery
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
    Dosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study.
Experimental
Continuous Regional Anesthesia Upper Limb Surgery
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
    Dosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study.
Experimental
Single Shot Regional Anesthesia Upper Limb Surgery
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
    Dosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study.

Recruiting Locations

More Details

NCT ID
NCT04669145
Status
Completed
Sponsor
Ochsner Health System

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.