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CompletedNCT04669145Updated Jul 29, 2025

Regional Anesthesia in Pediatric Orthopaedic Patients

A Phase 2/3 interventional study of Ropivacaine in Anesthesia, Local, Anesthesia and Orthopedic Disorder, sponsored by Ochsner Health System. Completed at 1 site in United States. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-07-29.

Sponsored by Ochsner Health System · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Apr 2024, 2 years 5 months ago, and no results have been posted to the registry.
Phase
Phase 2/3
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
5 Years to 18 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Anesthesia, Local
  • Anesthesia
  • Orthopedic Disorder
03

In context

Musculoskeletal Diseases

657 studies on the registry are indexed under Musculoskeletal Diseases; 159 are open to participants now.

This study's enrollment of 24 is below the median of 73 across 438 interventional studies indexed under Musculoskeletal Diseases.

Browse Musculoskeletal Diseases studies →

Lead sponsor

Ochsner Health System is the lead sponsor of 54 studies on the registry; 7 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 18 Years
Sexes eligible
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

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)
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • 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

  • 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

  • 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

  • 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

Interventions

  • DrugRopivacaine

    Dosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study.

06

What researchers measure

Primary outcomes

  1. Opioid Consumption

    Amount of opioid medications taken for pain control.

    Time frame: For first 48 hours post-operatively.

Secondary outcomes

  1. Opioid Consumption

    Amount of opioid medications taken for pain control.

    Time frame: Through 12 hours post-operatively.

  2. Opioid Consumption

    Amount of opioid medications taken for pain control.

    Time frame: Through 24 hours post-operatively.

  3. Opioid Consumption

    Amount of opioid medications taken for pain control.

    Time frame: Through 36 hours post-operatively.

  4. Opioid Consumption

    Amount of opioid medications taken for pain control.

    Time frame: Through 48 hours week post-operatively.

  5. Opioid Consumption

    Amount of opioid medications taken for pain control.

    Time frame: Through 72 hours post-operatively.

  6. Opioid Consumption

    Amount of opioid medications taken for pain control.

    Time frame: Through 96 hours post-operatively.

  7. Opioid Consumption

    Amount of opioid medications taken for pain control.

    Time frame: Through 120 hours post-operatively.

  8. Opioid Consumption

    Amount of opioid medications taken for pain control.

    Time frame: Through 144 hours post-operatively.

  9. Opioid Consumption

    Amount of opioid medications taken for pain control.

    Time frame: Through 168 hours post-operatively.

  10. Emergency Room Visits

    Emergency room visits due to poor pain control.

    Time frame: Within 2 weeks post-operatively.

  11. 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.

    Time frame: At 12 hours post-operatively.

  12. 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.

    Time frame: At 24 hours post-operatively.

  13. 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.

    Time frame: At 36 hours post-operatively.

  14. 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.

    Time frame: At 48 hours post-operatively.

  15. 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.

    Time frame: At 72 hours post-operatively.

  16. 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.

    Time frame: At 96 hours post-operatively.

  17. 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.

    Time frame: At 120 hours post-operatively.

  18. 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.

    Time frame: At 144 hours post-operatively.

  19. 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.

    Time frame: At 168 hours post-operatively.

  20. 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.

    Time frame: At 2 weeks post-operatively.

07

Study locations

1 site
  • Ochsner Medical Center
    Jefferson, Louisiana 70121, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04669145
Lead sponsor
Ochsner Health System
Responsible party
Sponsor
First posted
Dec 16, 2020
Start date
Jun 24, 2021
Primary completion
Apr 22, 2024
Completion
Apr 22, 2024
Last update
Jul 29, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.

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