Femoral FracturesNCT01294098
Efficacy Study of Femoral Nerve Block in Children With a Femur Fracture
A study testing Marcaine in people with Femoral Fractures and Pain, Postoperative, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
The purpose of this study is to examine the efficacy of the use of Marcaine in femoral nerve blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a pediatric population. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Femoral Fractures, Pain, Postoperative
- What is being tested?
- Marcaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to 8 Oct 2014
- Phase
- Interventional
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- A child with a femoral shaft fracture requiring surgical treatment and the placement of intramedullary nails
- Weight of 30-100 Kg
- Child must be older than 6 years old
Who cannot join
- Any child that had an open fracture
- A child that has a pain abnormality
- Any child with an allergy to local anesthetic
- Any child with a neurological injury
- Any child with the inability to report pain
- Any child that is unable to use a PCA post-operatively
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Louis Childrens Hospital
St Louis, Missouri, 63110
Washington University
St Louis, Missouri, 63110
About this study
Official title: Examining the Efficacy of Femoral Nerve Block in Children With a Femoral Shaft Fracture
The purpose of this study is to examine the efficacy of the use of Marcaine in femoral nerve blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a pediatric population.
Read the detailed description
Children with femur fractures can have severe pain after elastic nail fixation. The current national standard for post operative pain control would be intravenous narcotics. In addition to the use of intravenous narcotics, there are two alternative methods used during the surgery in order to potentially decrease the pain post-operatively. These methods are hematoma block or a femoral nerve block. Both are proven safe and effective in children, however little research has been done to look at the effectiveness of these various methods compared to one another.
- Conditions
- Femoral Fractures, Pain, Postoperative
- Being tested
- Marcaine
- Keywords
- Femoral Fractures, Pediatrics, Pain, Postoperative
- Medical subject headings
- Femoral Fractures, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarcaineDrug
Also called bupivacaine
0.75 cc/kg of 1/4% Marcaine
| Study group | Role | What they receive |
|---|---|---|
| PCA only | No intervention | this group will only get a pain control anesthesia pump to use for post-operative pain |
| PCA and femoral nerve block | Experimental | this group will be receiving a femoral nerve block during surgery and have a PCA post-operatively Receives: Drug: Marcaine |
| PCA + hematoma block | Experimental | patient will receive hematoma block during surgery Receives: Drug: Marcaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain Scores
We will be looking at post-operative pain scores to see if those in the intervention group have lower pains scores.
Wong Baker FACES pain scale:The faces correspond to numeric values from 0-5. This scale can be documented with the numeric value. The pain scale goes from 0-5 with 0 being no pain and 5 being the worst pain.
0: No Hurt
- Hurts a little bit
- Hurts a little more
- Hurts even more
- Hurts a whole lot
- Hurts worst
Measured: with in the first 24 hours
Post-operative Narcotic Use
We will be looking at the amount of narcotics used after surgery to see if there is a reduction in narcotic use
Measured: within first 24 horus
Secondary outcomes (1)
Femur Fracture Healing
we will following patients to look at fracture healing post-operatively
Measured: first year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completion8 Oct 2013
- Study completion8 Oct 2014
Why it stopped: Patients were not willing to be randomized and therefore recruitment could not continue.
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 Femoral FracturesStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. Eric Gordon, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01294098
- Sponsor's protocol ID
- 10-0331
- Status last verified
- Mar 2018
- First submitted
- 9 Feb 2011
- Last updated
- 30 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Efficacy of Femoral Nerve Block in Children With a Femoral Shaft Fracture
- ClinicalTrials.gov ID
- NCT01294098
- Acronym / sponsor ID
- 10-0331
- Conditions
- Femoral Fractures, Pain, Postoperative
- Keywords
- Femoral Fractures, Pediatrics, Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Patients were not willing to be randomized and therefore recruitment could not continue.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Feb 2011 (actual)
- Primary completion
- 8 Oct 2013 (actual)
- Study completion
- 8 Oct 2014 (actual)
- First posted
- 11 Feb 2011 (estimated)
- Results
- Posted 30 Mar 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 examine the efficacy of the use of Marcaine in femoral nerve blocks and hematoma blocks for post operative pain relief for femoral shaft fractures in a pediatric population.
Detailed description
Children with femur fractures can have severe pain after elastic nail fixation. The current national standard for post operative pain control would be intravenous narcotics. In addition to the use of intravenous narcotics, there are two alternative methods used during the surgery in order to potentially decrease the pain post-operatively. These methods are hematoma block or a femoral nerve block. Both are proven safe and effective in children, however little research has been done to look at the effectiveness of these various methods compared to one another.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PCA only | No intervention | –this group will only get a pain control anesthesia pump to use for post-operative pain |
| PCA and femoral nerve block | Experimental | Drug: Marcainethis group will be receiving a femoral nerve block during surgery and have a PCA post-operatively |
| PCA + hematoma block | Experimental | Drug: Marcainepatient will receive hematoma block during surgery |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- A child with a femoral shaft fracture requiring surgical treatment and the placement of intramedullary nails
- Weight of 30-100 Kg
- Child must be older than 6 years old
Key exclusion criteria (6 listed)
- Any child that had an open fracture
- A child that has a pain abnormality
- Any child with an allergy to local anesthetic
- Any child with a neurological injury
- Any child with the inability to report pain
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 |
|---|---|---|
| MarcaineAlso: bupivacaine0.75 cc/kg of 1/4% Marcaine | Drug | PCA + hematoma block, PCA and femoral nerve block |
Primary outcome
Post-operative Pain Scores
Time frame: with in the first 24 hours
We will be looking at post-operative pain scores to see if those in the intervention group have lower pains scores. Wong Baker FACES pain scale:The faces correspond to numeric values from 0-5. This scale can be documented with the numeric value. The pain scale goes from 0-5 with 0 being no pain and 5 being the worst pain. 0: No Hurt 1. Hurts a little bit 2. Hurts a little more 3. Hurts even more 4. Hurts a whole lot 5. Hurts worst
Post-operative Narcotic Use
Time frame: within first 24 horus
We will be looking at the amount of narcotics used after surgery to see if there is a reduction in narcotic use
1 secondary outcome
Femur Fracture Healing
Time frame: first year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 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.
J. Eric Gordon, MD principal investigator
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Marcaine in people with Femoral Fractures and Pain, Postoperative, run by Washington University School of Medicine at 2 sites 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 6 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 30 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 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-operative Pain Scores (time frame: with in the first 24 hours). The study lists 2 primary outcomes in all. 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 30 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.