Regional Anesthesia in Pediatric Orthopaedic Patients

July 25, 2025 updated by: Ochsner Health System

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: For first 48 hours post-operatively.
Amount of opioid medications taken for pain control.
For first 48 hours post-operatively.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opioid Consumption
Time Frame: Through 12 hours post-operatively.
Amount of opioid medications taken for pain control.
Through 12 hours post-operatively.
Opioid Consumption
Time Frame: Through 24 hours post-operatively.
Amount of opioid medications taken for pain control.
Through 24 hours post-operatively.
Opioid Consumption
Time Frame: Through 36 hours post-operatively.
Amount of opioid medications taken for pain control.
Through 36 hours post-operatively.
Opioid Consumption
Time Frame: Through 48 hours week post-operatively.
Amount of opioid medications taken for pain control.
Through 48 hours week post-operatively.
Opioid Consumption
Time Frame: Through 72 hours post-operatively.
Amount of opioid medications taken for pain control.
Through 72 hours post-operatively.
Opioid Consumption
Time Frame: Through 96 hours post-operatively.
Amount of opioid medications taken for pain control.
Through 96 hours post-operatively.
Opioid Consumption
Time Frame: Through 120 hours post-operatively.
Amount of opioid medications taken for pain control.
Through 120 hours post-operatively.
Opioid Consumption
Time Frame: Through 144 hours post-operatively.
Amount of opioid medications taken for pain control.
Through 144 hours post-operatively.
Opioid Consumption
Time Frame: Through 168 hours post-operatively.
Amount of opioid medications taken for pain control.
Through 168 hours post-operatively.
Emergency Room Visits
Time Frame: Within 2 weeks post-operatively.
Emergency room visits due to poor pain control.
Within 2 weeks post-operatively.
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.
At 12 hours post-operatively.
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.
At 24 hours post-operatively.
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.
At 36 hours post-operatively.
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.
At 48 hours post-operatively.
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.
At 72 hours post-operatively.
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.
At 96 hours post-operatively.
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.
At 120 hours post-operatively.
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.
At 144 hours post-operatively.
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.
At 168 hours post-operatively.
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.
At 2 weeks post-operatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ochsner Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 22, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 22, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 16, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings