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Completed

NCT Number: NCT04669145

Regional Anesthesia in Pediatric Orthopaedic Patients

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.

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Key information

Conditions

Anesthesia, Local Anesthesia Musculoskeletal Diseases Orthopedic Disorder

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Ochsner Medical Center

Jefferson, Louisiana, 70121, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ropivacaine

Drug

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

Primary outcomes

  1. Opioid Consumption

    Time frame: For first 48 hours post-operatively.

    Amount of opioid medications taken for pain control.

Secondary outcomes

  1. Opioid Consumption

    Time frame: Through 12 hours post-operatively.

    Amount of opioid medications taken for pain control.

  2. Opioid Consumption

    Time frame: Through 24 hours post-operatively.

    Amount of opioid medications taken for pain control.

  3. Opioid Consumption

    Time frame: Through 36 hours post-operatively.

    Amount of opioid medications taken for pain control.

  4. Opioid Consumption

    Time frame: Through 48 hours week post-operatively.

    Amount of opioid medications taken for pain control.

  5. Opioid Consumption

    Time frame: Through 72 hours post-operatively.

    Amount of opioid medications taken for pain control.

  6. Opioid Consumption

    Time frame: Through 96 hours post-operatively.

    Amount of opioid medications taken for pain control.

  7. Opioid Consumption

    Time frame: Through 120 hours post-operatively.

    Amount of opioid medications taken for pain control.

  8. Opioid Consumption

    Time frame: Through 144 hours post-operatively.

    Amount of opioid medications taken for pain control.

  9. Opioid Consumption

    Time frame: Through 168 hours post-operatively.

    Amount of opioid medications taken for pain control.

  10. Emergency Room Visits

    Time frame: Within 2 weeks post-operatively.

    Emergency room visits due to poor pain control.

  11. Pain Scores

    Time frame: At 12 hours 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.

  12. Pain Scores

    Time frame: At 24 hours 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.

  13. Pain Scores

    Time frame: At 36 hours 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.

  14. Pain Scores

    Time frame: At 48 hours 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.

  15. Pain Scores

    Time frame: At 72 hours 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.

  16. Pain Scores

    Time frame: At 96 hours 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.

  17. Pain Scores

    Time frame: At 120 hours 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.

  18. Pain Scores

    Time frame: At 144 hours 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.

  19. Pain Scores

    Time frame: At 168 hours 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.

  20. Pain Scores

    Time frame: At 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.

Sponsors and collaborators

Lead sponsor

Ochsner Health System

Other

Registry information

Official study title

Single-Shot Versus Continuous Regional Anesthesia for Treating Acute Postoperative Pain in Pediatric Orthopaedic Surgery: A Prospective Randomized Trial

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 16, 2020
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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