Anesthesia, LocalPhase 2/3NCT04669145
Regional Anesthesia in Pediatric Orthopaedic Patients
A Phase 2/3 study testing Ropivacaine in people with Anesthesia, Local and Anesthesia, run by Ochsner Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Anesthesia, Local, Anesthesia, Orthopedic Disorder
- What is being tested?
- Ropivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2021to 22 Apr 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients undergoing primary orthopaedic limb surgery
- Outpatient orthopaedic surgeries
- Patients undergoing orthopaedic surgery who would normally receive regional anesthesia
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Anesthesia, Local, Anesthesia, Orthopedic Disorder
- Being tested
- Ropivacaine
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Dosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study.
| Study group | Role | What they receive |
|---|---|---|
| Continuous Regional Anesthesia Lower Limb Surgery | Experimental | 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. Receives: Drug: Ropivacaine |
| Single Shot Regional Anesthesia Lower Limb Surgery | Experimental | 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. Receives: Drug: Ropivacaine |
| Continuous Regional Anesthesia Upper Limb Surgery | Experimental | 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. Receives: Drug: Ropivacaine |
| Single Shot Regional Anesthesia Upper Limb Surgery | Experimental | 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. Receives: Drug: Ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Amount of opioid medications taken for pain control.
Measured: For first 48 hours post-operatively.
Secondary outcomes (20)
Opioid Consumption
Amount of opioid medications taken for pain control.
Measured: Through 12 hours post-operatively.
Opioid Consumption
Amount of opioid medications taken for pain control.
Measured: Through 24 hours post-operatively.
Opioid Consumption
Amount of opioid medications taken for pain control.
Measured: Through 36 hours post-operatively.
Opioid Consumption
Amount of opioid medications taken for pain control.
Measured: Through 48 hours week post-operatively.
Opioid Consumption
Amount of opioid medications taken for pain control.
Measured: Through 72 hours post-operatively.
Opioid Consumption
Amount of opioid medications taken for pain control.
Measured: Through 96 hours post-operatively.
Opioid Consumption
Amount of opioid medications taken for pain control.
Measured: Through 120 hours post-operatively.
Opioid Consumption
Amount of opioid medications taken for pain control.
Measured: Through 144 hours post-operatively.
Opioid Consumption
Amount of opioid medications taken for pain control.
Measured: Through 168 hours post-operatively.
Emergency Room Visits
Emergency room visits due to poor pain control.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 2 weeks post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start24 Jun 2021
- Primary completion22 Apr 2024
- Study completion22 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ochsner Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04669145
- Sponsor's protocol ID
- 2020.403
- Status last verified
- Jul 2025
- First submitted
- 6 Dec 2020
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Shot Versus Continuous Regional Anesthesia for Treating Acute Postoperative Pain in Pediatric Orthopaedic Surgery: A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT04669145
- Acronym / sponsor ID
- 2020.403
- Conditions
- Anesthesia, Local, Anesthesia, Orthopedic Disorder
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ochsner Health SystemUniversity, hospital or other
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 22 Apr 2024 (actual)
- Study completion
- 22 Apr 2024 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Continuous Regional Anesthesia Lower Limb Surgery | Experimental | Drug: RopivacaineVarious 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. |
| Single Shot Regional Anesthesia Lower Limb Surgery | Experimental | Drug: RopivacaineVarious 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. |
| Continuous Regional Anesthesia Upper Limb Surgery | Experimental | Drug: RopivacaineVarious 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. |
| Single Shot Regional Anesthesia Upper Limb Surgery | Experimental | Drug: RopivacaineVarious 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. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients undergoing primary orthopaedic limb surgery
- Outpatient orthopaedic surgeries
- Patients undergoing orthopaedic surgery who would normally receive regional anesthesia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineDosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study. | Drug | Continuous Regional Anesthesia Lower Limb Surgery, Continuous Regional Anesthesia Upper Limb Surgery, Single Shot Regional Anesthesia Lower Limb Surgery, Single Shot Regional Anesthesia Upper Limb Surgery |
Primary outcome
Opioid Consumption
Time frame: For first 48 hours post-operatively.
Amount of opioid medications taken for pain control.
20 secondary outcomes
Opioid Consumption
Time frame: Through 12 hours post-operatively.
Opioid Consumption
Time frame: Through 24 hours post-operatively.
Opioid Consumption
Time frame: Through 36 hours post-operatively.
Opioid Consumption
Time frame: Through 48 hours week post-operatively.
Opioid Consumption
Time frame: Through 72 hours post-operatively.
Opioid Consumption
Time frame: Through 96 hours post-operatively.
Opioid Consumption
Time frame: Through 120 hours post-operatively.
Opioid Consumption
Time frame: Through 144 hours post-operatively.
Opioid Consumption
Time frame: Through 168 hours post-operatively.
Emergency Room Visits
Time frame: Within 2 weeks post-operatively.
Pain Scores
Time frame: At 12 hours post-operatively.
Pain Scores
Time frame: At 24 hours post-operatively.
Pain Scores
Time frame: At 36 hours post-operatively.
Pain Scores
Time frame: At 48 hours post-operatively.
Pain Scores
Time frame: At 72 hours post-operatively.
Pain Scores
Time frame: At 96 hours post-operatively.
Pain Scores
Time frame: At 120 hours post-operatively.
Pain Scores
Time frame: At 144 hours post-operatively.
Pain Scores
Time frame: At 168 hours post-operatively.
Pain Scores
Time frame: At 2 weeks post-operatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ropivacaine in people with Anesthesia, Local and Anesthesia, run by Ochsner Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opioid Consumption (time frame: For first 48 hours post-operatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2025; AzTrials last refreshed its copy on 6 Nov 2026.