Other Reconstructive SurgeryNCT01293136
Retrospective Femoral Nerve Block Study
An observational study of Other Reconstructive Surgery, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This is a retrospective review to evaluate the efficacy of femoral nerve block in providing analgesia following reconstructive surgery of the knee and to compare the postoperative course of patients who received femoral nerve block with a retrospective cohort who were cared for prior to the institution of a regional… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Other Reconstructive Surgery
- What is being tested?
- Femoral nerve block and Intravenous opioids
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to Dec 2011
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients that had reconstructive knee surgery
Who may be able to join
- Patients that had reconstructive knee surgery between July 2009 to the present.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
This is a retrospective review to evaluate the efficacy of femoral nerve block in providing analgesia following reconstructive surgery of the knee and to compare the postoperative course of patients who received femoral nerve block with a retrospective cohort who were cared for prior to the institution of a regional anesthesia program. The investigators hypothesize that femoral nerve blockade limits postoperative opioid needs, improves analgesia and facilitates discharge home when compared to intravenous opioid use following reconstructive knee surgery.
- Conditions
- Other Reconstructive Surgery
- Being tested
- Femoral nerve block, Intravenous opioids
- Keywords
- knee, reconstructive surgery, femoral nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve blockProcedure or surgery
Ropivacaine
Intravenous opioidsDrug
Whatever opioids prescribed
| Study group | Role | What they receive |
|---|---|---|
| intravenous opioids | Not described Receives: Drug: Intravenous opioids | |
| femoral nerve block | Not described Receives: Procedure: Femoral nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of hospitalization
duration of hospitalization and need for inpatient admission in patients who received femoral nerve block versus those who received intravenous opioids
Measured: 1 Week
Secondary outcomes (3)
Nausea and vomiting
Measured: 1 Week
Total opioid use
Measured: 1 Week
Postoperative pain score
Measured: 1 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Reconstructive SurgeryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph D. Tobias, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01293136
- Sponsor's protocol ID
- IRB11-00073
- Status last verified
- Jan 2012
- First submitted
- 9 Feb 2011
- Last updated
- 31 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Femoral Nerve Block Study
- ClinicalTrials.gov ID
- NCT01293136
- Acronym / sponsor ID
- IRB11-00073
- Conditions
- Other Reconstructive Surgery
- Keywords
- knee, reconstructive surgery, femoral nerve block
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Feb 2011 (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 is a retrospective review to evaluate the efficacy of femoral nerve block in providing analgesia following reconstructive surgery of the knee and to compare the postoperative course of patients who received femoral nerve block with a retrospective cohort who were cared for prior to the institution of a regional anesthesia program. The investigators hypothesize that femoral nerve blockade limits postoperative opioid needs, improves analgesia and facilitates discharge home when compared to intravenous opioid use following reconstructive knee surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intravenous opioids | – | Drug: Intravenous opioids |
| femoral nerve block | – | Procedure: Femoral nerve block |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients that had reconstructive knee surgery
Key inclusion criteria (1 listed)
- Patients that had reconstructive knee surgery between July 2009 to the present.
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Femoral nerve blockRopivacaine | Procedure or surgery | femoral nerve block |
| Intravenous opioidsWhatever opioids prescribed | Drug | intravenous opioids |
Primary outcome
Duration of hospitalization
Time frame: 1 Week
duration of hospitalization and need for inpatient admission in patients who received femoral nerve block versus those who received intravenous opioids
3 secondary outcomes
Nausea and vomiting
Time frame: 1 Week
Total opioid use
Time frame: 1 Week
Postoperative pain score
Time frame: 1 Week
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 31 Jan 2012.
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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?
An observational study of Other Reconstructive Surgery, 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 1 inclusion and 1 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 31 Jan 2012. 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.
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?
Duration of hospitalization (time frame: 1 Week). 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 31 Jan 2012.