Traumatic Femur FracturePhase 2NCT01759407
Femoral Nerve Block for Femur Fracture Repair in Pediatrics
A Phase 2 study testing Ropivicaine and Epinephrine in people with Traumatic Femur Fracture, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing traumatic femur fracture repair who have received either a femoral nerve block with a lateral femoral cutaneous nerve block or a standard anesthetic for analgesia. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Traumatic Femur Fracture
- What is being tested?
- Ropivicaine and Epinephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to Oct 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I or II
- Weight greater than or equal to 10kg
- Presenting for repair of traumatic femur fracture
Who cannot join
- ASA physical status > II
- Co-morbid diseases (cardiac, pulmonary, neurological disease)
- Patients having concomitant procedures
- Abnormal neurovascular examination in the injured leg
- Presence of vascular compromise in the affected lower extremity
- Mechanism of sustained injury via crush injury
- Use of therapeutic dose anticoagulants or presence of a bleeding disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Double-blinded, Randomized Comparison of Ultrasound-guided Femoral Nerve Block With Lateral Femoral Cutaneous Nerve Block Versus Standard Anesthetic Management for Traumatic Femur Fracture Repair in the Pediatric Population
The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing traumatic femur fracture repair who have received either a femoral nerve block with a lateral femoral cutaneous nerve block or a standard anesthetic for analgesia.
- Conditions
- Traumatic Femur Fracture
- Being tested
- Ropivicaine, Epinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivicaineDrug
Also called Naropin
EpinephrineDrug
| Study group | Role | What they receive |
|---|---|---|
| Femoral Nerve Block | Active comparator | Ropivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg Receives: Drug: Ropivicaine; Drug: Epinephrine |
| Standard Anesthetic Management | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-anesthesia Care Unit (PACU) Pain Scores
Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.
Measured: 30 mins after surgery
Secondary outcomes (2)
Intraoperative End-tidal Isoflurane %
Median end-tidal isoflurane concentration per participant during the average 1 1/2 hr. surgery.
Measured: 1 1/2 hr.
Time to First Opioid Dose
Median time between PACU discharge and first opioid dose on the ward.
Measured: From PACU discharge until first opioid dose on the ward, assessed up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2016
- Study completionOct 2016
Why it stopped: Interim analysis showed no significant difference between study arms.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Traumatic Femur FractureStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicole Elsey, Nationwide Children's Hospital
- Investigators
- Nicole Elsey, MD, Principal investigator, Nationwide Children's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759407
- Sponsor's protocol ID
- IRB16-00338
- Status last verified
- Jan 2018
- First submitted
- 29 Dec 2012
- Last updated
- 25 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blinded, Randomized Comparison of Ultrasound-guided Femoral Nerve Block With Lateral Femoral Cutaneous Nerve Block Versus Standard Anesthetic Management for Traumatic Femur Fracture Repair in the Pediatric Population
- ClinicalTrials.gov ID
- NCT01759407
- Acronym / sponsor ID
- IRB16-00338
- Conditions
- Traumatic Femur Fracture
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis showed no significant difference between study arms.
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 3 Jan 2013 (estimated)
- Results
- Posted 25 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to prospectively compare post-operative pain relief in pediatric patients undergoing traumatic femur fracture repair who have received either a femoral nerve block with a lateral femoral cutaneous nerve block or a standard anesthetic for analgesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral Nerve Block | Active comparator | Drug: Ropivicaine, Drug: EpinephrineRopivicaine 0.2% with epinephrine 1:200,000 will be used for patients between 10kg and up to 25kg in weight; ropivicaine 0.5% with epinephrine 1:200,000 will be used for patients greater than or equal to 25kg |
| Standard Anesthetic Management | No intervention | – |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- American Society of Anesthesiologists (ASA) physical status I or II
- Weight greater than or equal to 10kg
- Presenting for repair of traumatic femur fracture
Key exclusion criteria (7 listed)
- ASA physical status > II
- Co-morbid diseases (cardiac, pulmonary, neurological disease)
- Patients having concomitant procedures
- Abnormal neurovascular examination in the injured leg
- Presence of vascular compromise in the affected lower extremity
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 |
|---|---|---|
| RopivicaineAlso: Naropin | Drug | Femoral Nerve Block |
| Epinephrine | Drug | Femoral Nerve Block |
Primary outcome
Post-anesthesia Care Unit (PACU) Pain Scores
Time frame: 30 mins after surgery
Hannallah et al developed the Objective Pain Scale (OPS) to monitor pain in children after surgery. Parameters: (1) systolic blood pressure, (2) crying, (3) movement, (4) agitation (confused, excited), (5) complains of pain (may not be possible in younger children). Interpretation: minimum score: 0; maximum score: 10; maximum score if too young to complain of pain: 8; the higher the score, the greater the degree of pain.
2 secondary outcomes
Intraoperative End-tidal Isoflurane %
Time frame: 1 1/2 hr.
Time to First Opioid Dose
Time frame: From PACU discharge until first opioid dose on the ward, assessed up to 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Nicole Elsey, MD principal investigator
Nationwide Children's
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ropivicaine and Epinephrine in people with Traumatic Femur Fracture, run by Nationwide Children's Hospital 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: stopped early, as of the sponsor's last update on 25 Jan 2018. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Post-anesthesia Care Unit (PACU) Pain Scores (time frame: 30 mins after surgery). 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 25 Jan 2018.