Pain, PostoperativePhase 1NCT00175591
The Effect of Femoral Nerve Block on Opioid Requirements After Surgery for a Femur Fracture in Children
A Phase 1 study testing Administration of a femoral nerve block (bupivacaine HCL) in people with Pain, Postoperative, run by University of British Columbia at 1 site in Canada.
Trial summary
This study evaluates the effect of a femoral nerve block on opioid requirements following femoral fracture fixation with flexible nails in the paediatric population. This is a double blind, prospective randomized clinical trial. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Administration of a femoral nerve block (bupivacaine HCL)
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2007to Jun 2011
- Phase
- Phase 1
- 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 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Femoral shaft fracture requiring intra-medullary nailing
- Surgery performed within 24 hours of injury
- Ability of child or family to use patient-controlled analgesia (PCA)
- No allergy or sensitivity to bupivacaine
- Informed consent and assent
Who cannot join
- Open femur fractures
- Closed fractures needing open reduction
- Fractures associated with neurovascular complications
- Fractures associated with compartment syndrome
- Repeat femoral surgeries
- Patients who received a femoral nerve block more than 1 hour prior to surgery
- Complex associated injuries or pre-existing condition that will delay time to ambulation
- Children who are allergic and/or sensitive to bupivacaine
Trial locations and contacts
1 site in 1 country.
Canada1 site
British Columbia Children's Hospital, Department of Orthopaedics
Vancouver, British Columbia, V6H 3V4
About this study
Official title: The Effect of Femoral Nerve Block on Opioid Requirements Following Femoral Fracture Fixation With Flexible Nails in the Paediatric Population: A Double Blind, Prospective Randomized Clinical Trial
This study evaluates the effect of a femoral nerve block on opioid requirements following femoral fracture fixation with flexible nails in the paediatric population. This is a double blind, prospective randomized clinical trial.
- Conditions
- Pain, Postoperative
- Being tested
- Administration of a femoral nerve block (bupivacaine HCL)
- Keywords
- Femur fracture, morphine sparing, preemptive analgesia, Post-operative pain and post- operative opioid use
- Medical subject headings
- Pain, Postoperative, Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Administration of a femoral nerve block (bupivacaine HCL)Procedure or surgery
No details specified
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded
Measured: until patient discharge
Secondary outcomes (4)
Pain rating
Measured: immediately post-op
Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate
Measured: every 8 hours
Time to discharge
Measured: from end of surgery
Time (hours) from end of surgery to sitting on bed with legs hanging over the side
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startAug 2007
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kishore Mulpuri, University of British Columbia
- Investigators
- Kishore Mulpuri, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175591
- Sponsor's protocol ID
- H05-70077
- Other IDs
- W05-0025
- Status last verified
- Jan 2018
- First submitted
- 13 Sep 2005
- Last updated
- 10 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Femoral Nerve Block on Opioid Requirements Following Femoral Fracture Fixation With Flexible Nails in the Paediatric Population: A Double Blind, Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00175591
- Acronym / sponsor ID
- H05-70077
- Conditions
- Pain, Postoperative
- Keywords
- Femur fracture, morphine sparing, preemptive analgesia, Post-operative pain and post- operative opioid use
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 15 Sep 2005 (estimated)
- 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.
This study evaluates the effect of a femoral nerve block on opioid requirements following femoral fracture fixation with flexible nails in the paediatric population. This is a double blind, prospective randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Femoral shaft fracture requiring intra-medullary nailing
- Surgery performed within 24 hours of injury
- Ability of child or family to use patient-controlled analgesia (PCA)
- No allergy or sensitivity to bupivacaine
- Informed consent and assent
Key exclusion criteria (8 listed)
- Open femur fractures
- Closed fractures needing open reduction
- Fractures associated with neurovascular complications
- Fractures associated with compartment syndrome
- Repeat femoral surgeries
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 |
|---|---|---|
| Administration of a femoral nerve block (bupivacaine HCL)No details specified | Procedure or surgery | – |
Primary outcome
Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded
Time frame: until patient discharge
4 secondary outcomes
Pain rating
Time frame: immediately post-op
Sedation/pruritis/nausea/vomiting/urinary retention/respiratory rate
Time frame: every 8 hours
Time to discharge
Time frame: from end of surgery
Time (hours) from end of surgery to sitting on bed with legs hanging over the side
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 10 Jan 2018.
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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.
Kishore Mulpuri, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Administration of a femoral nerve block (bupivacaine HCL) in people with Pain, Postoperative, run by University of British Columbia at 1 site in Canada.
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 5 inclusion and 8 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 10 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 Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Postoperative morphine requirement; the average 8 hour morphine requirement (mcg/kg/hr) will be recorded (time frame: until patient discharge). 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 10 Jan 2018.