Pain, PostoperativePhase 1NCT00175630
The Effect of Femoral Nerve Block on Postoperative Opioid Use After Anterior Cruciate Ligament (ACL) Reconstruction
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 anterior cruciate ligament (ACL) reconstruction. This is a double blind, prospective randomized controlled trial. Read more about this study
- Who is it for?
- Ages 12 to 17 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
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2010to Sep 2016
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Schedule for primary elective anterior cruciate ligament reconstruction
- Tolerance to bupivacaine
- Tolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
- Informed consent
Who cannot join
- Patients who received a femoral nerve block more than 1 hour prior to surgery
- Complex associated injuries or pre-existing conditions that will delay time to ambulation
- Children with tibial avulsion fractures
- Allergic and/or sensitive to bupivacaine and/or NSAIDs
- 30% over ideal body weight
- Acute ACL reconstruction (done less than 2 weeks after injury)
Show all 10Show fewer
- Pre-existing femoral nerve injury
- Psychiatric patients on psychotropic agents
- History of drug or alcohol dependence or recreational drug use
- Refusal to provide informed consent
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: Effect of Femoral Nerve Block on Opioid Requirements Following Anterior Cruciate Ligament Reconstruction: A Double Blind, Prospective Randomized Controlled Trial
This study evaluates the effect of a femoral nerve block on opioid requirements following anterior cruciate ligament (ACL) reconstruction. This is a double blind, prospective randomized controlled trial.
- Conditions
- Pain, Postoperative
- Being tested
- Administration of a femoral nerve block (bupivacaine HCL)
- Keywords
- ACL reconstruction, morphine sparing, preemptive analgesia, Post-operative pain and post- operative opioid use
- Medical subject headings
- Pain, Postoperative
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
See Detailed Description
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine requirement
Secondary outcomes (2)
Pain rating
Measured: immediately post-op
Opioid surgical time
Measured: time from end of anaesthesia to first requirement of morphine
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 startDec 2010
- Primary completionSep 2011
- Study completionSep 2016 (estimated)
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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christopher Reilly, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00175630
- Sponsor's protocol ID
- H05-70078
- Other IDs
- W05-0024
- Status last verified
- May 2016
- First submitted
- 13 Sep 2005
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Femoral Nerve Block on Opioid Requirements Following Anterior Cruciate Ligament Reconstruction: A Double Blind, Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00175630
- Acronym / sponsor ID
- H05-70078
- Conditions
- Pain, Postoperative
- Keywords
- ACL reconstruction, morphine sparing, preemptive analgesia, Post-operative pain and post- operative opioid use
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2016 (estimated)
- 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 anterior cruciate ligament (ACL) reconstruction. This is a double blind, prospective randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Schedule for primary elective anterior cruciate ligament reconstruction
- Tolerance to bupivacaine
- Tolerance to non-steroidal anti-inflammatory drugs (NSAIDs)
- Informed consent
Key exclusion criteria (10 listed)
- Patients who received a femoral nerve block more than 1 hour prior to surgery
- Complex associated injuries or pre-existing conditions that will delay time to ambulation
- Children with tibial avulsion fractures
- Allergic and/or sensitive to bupivacaine and/or NSAIDs
- 30% over ideal body weight
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)See Detailed Description | Procedure or surgery | – |
Primary outcome
Postoperative morphine requirement
2 secondary outcomes
Pain rating
Time frame: immediately post-op
Opioid surgical time
Time frame: time from end of anaesthesia to first requirement of morphine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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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.
Christopher Reilly, 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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 1 Jun 2016. 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?
Results are not available in the source record.
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. 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 1 Jun 2016.