Regional Anesthesia in Pediatric Orthopaedic Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local; Anesthesia; Orthopedic Disorder
• Intervention / Treatment: Drug: Ropivacaine

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Jefferson, Louisiana, United States, 70121
      • Ochsner Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Amount of opioid medications taken for pain control.	For first 48 hours post-operatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid Consumption	Amount of opioid medications taken for pain control.	Through 12 hours post-operatively.
Opioid Consumption	Amount of opioid medications taken for pain control.	Through 24 hours post-operatively.
Opioid Consumption	Amount of opioid medications taken for pain control.	Through 36 hours post-operatively.
Opioid Consumption	Amount of opioid medications taken for pain control.	Through 48 hours week post-operatively.
Opioid Consumption	Amount of opioid medications taken for pain control.	Through 72 hours post-operatively.
Opioid Consumption	Amount of opioid medications taken for pain control.	Through 96 hours post-operatively.
Opioid Consumption	Amount of opioid medications taken for pain control.	Through 120 hours post-operatively.
Opioid Consumption	Amount of opioid medications taken for pain control.	Through 144 hours post-operatively.
Opioid Consumption	Amount of opioid medications taken for pain control.	Through 168 hours post-operatively.
Emergency Room Visits	Emergency room visits due to poor pain control.	Within 2 weeks post-operatively.
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.	At 12 hours post-operatively.
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.	At 24 hours post-operatively.
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.	At 36 hours post-operatively.
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.	At 48 hours post-operatively.
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.	At 72 hours post-operatively.
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.	At 96 hours post-operatively.
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.	At 120 hours post-operatively.
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.	At 144 hours post-operatively.
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.	At 168 hours post-operatively.
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.	At 2 weeks post-operatively.

Collaborators and Investigators

• Sponsor: Ochsner Health System

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2021
• Primary Completion (Actual): April 22, 2024
• Study Completion (Actual): April 22, 2024

Study Registration Dates

• First Submitted: December 6, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (Actual): December 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 25, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Ropivacaine
• Other Study ID Numbers: 2020.403

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No