Postoperative PainNCT02501135
A Retrospective Investigation of Local Anesthetic Concentrations in Femoral Nerve Block
An observational study of Postoperative Pain, run by Giorgio Veneziano.
Trial summary
The purpose of this study is to retrospectively compare perioperative pain relief and safety in pediatric patients who have received a femoral nerve block with varying concentrations of local anesthetic. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Femoral nerve block with ropivacaine or bupivacaine
- Type of treatment
- Surgery or procedure
- How many people
- 281 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to May 2016
- Phase
- Observational
- 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
Study population: Patients who have undergone anesthesia and received a femoral nerve block at Nationwide Children'ts Hospital from 2010-2015 utilizing our EMR - PICIS.
Who may be able to join
- ASA physical status I or II
- Age < or equal to 18 years of age at time of femoral nerve block
- Femoral nerve block performed from 2010-2015
Who cannot join
- ASA physical status > II
- Co-morbid diseases (cardiac, pulmonary, neurological disease)
- Use of adjunctive medications in femoral nerve block (except for epinephrine), such as dexamethasone
About this study
Official title: A Retrospective Investigation of Safety and Efficacy From Increasing Concentrations of Local Anesthetic in Pediatric Femoral Nerve Blocks
The purpose of this study is to retrospectively compare perioperative pain relief and safety in pediatric patients who have received a femoral nerve block with varying concentrations of local anesthetic.
- Conditions
- Postoperative Pain
- Being tested
- Femoral nerve block with ropivacaine or bupivacaine
- Keywords
- Femoral nerve blocks, children, knee and thigh surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femoral nerve block with ropivacaine or bupivacaineProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Femoral Nerve Blocks | Patients who receive ropivacaine or bupivacaine during femoral nerve block. Receives: Procedure: Femoral nerve block with ropivacaine or bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Local Anesthetic Injected for Femoral Nerve Block
Measured: length of surgery
Total mg of Local Anesthetic Injected for Femoral Nerve Block
Measured: length of surgery
Intraoperative Tylenol Administered
Amount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block.
Measured: length of surgery
Post-operative Opioids Administered
Amount of opioid consumption in the post operative anesthesia care unit depending on if the patient received femoral nerve block with ropivacaine or bupivacaine
Measured: in PACU (1 hr post-op)
Secondary outcomes (3)
Time to Discharge From PACU
Measured: Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hour
Post-operative Pain Scale Using FLACC
The Face, Legs, Activity, Cry, Consolability scale or FLACC scale is a measurement used to assess pain for children between the ages of 2 months and 7 years or individuals that are unable to communicate their pain. The scale is scored in a range of 0-10 with 0 representing no pain.
Measured: 1 hour post-op
Post-operative Pain Scale Using VAS
The visual analogue scale (VAS) for pain is a validated, subjective measure where scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain."
Measured: 1 hour post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionMay 2016
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 Postoperative PainStudies 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
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Giorgio Veneziano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Giorgio Veneziano, Nationwide Children's Hospital
- Investigators
- Giorgio Veneziano, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501135
- Sponsor's protocol ID
- IRB 15-00396
- Status last verified
- Nov 2018
- First submitted
- 28 May 2015
- Last updated
- 6 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Investigation of Safety and Efficacy From Increasing Concentrations of Local Anesthetic in Pediatric Femoral Nerve Blocks
- ClinicalTrials.gov ID
- NCT02501135
- Acronym / sponsor ID
- IRB 15-00396
- Conditions
- Postoperative Pain
- Keywords
- Femoral nerve blocks, children, knee and thigh surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Giorgio VenezianoUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Posted 6 Mar 2019
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 retrospectively compare perioperative pain relief and safety in pediatric patients who have received a femoral nerve block with varying concentrations of local anesthetic.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Femoral Nerve Blocks | – | Procedure: Femoral nerve block with ropivacaine or bupivacainePatients who receive ropivacaine or bupivacaine during femoral nerve block. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who have undergone anesthesia and received a femoral nerve block at Nationwide Children'ts Hospital from 2010-2015 utilizing our EMR - PICIS.
Key inclusion criteria (3 listed)
- ASA physical status I or II
- Age < or equal to 18 years of age at time of femoral nerve block
- Femoral nerve block performed from 2010-2015
Key exclusion criteria (3 listed)
- ASA physical status > II
- Co-morbid diseases (cardiac, pulmonary, neurological disease)
- Use of adjunctive medications in femoral nerve block (except for epinephrine), such as dexamethasone
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 block with ropivacaine or bupivacaine | Procedure or surgery | Femoral Nerve Blocks |
Primary outcome
Concentration of Local Anesthetic Injected for Femoral Nerve Block
Time frame: length of surgery
Total mg of Local Anesthetic Injected for Femoral Nerve Block
Time frame: length of surgery
Intraoperative Tylenol Administered
Time frame: length of surgery
Amount of Tylenol administered based on if got ropivacaine or bupivacaine femeral nerve block.
Post-operative Opioids Administered
Time frame: in PACU (1 hr post-op)
Amount of opioid consumption in the post operative anesthesia care unit depending on if the patient received femoral nerve block with ropivacaine or bupivacaine
3 secondary outcomes
Time to Discharge From PACU
Time frame: Conclusion of surgery until admission to assigned unit or to phase, an expected average of 1 hour
Post-operative Pain Scale Using FLACC
Time frame: 1 hour post-op
Post-operative Pain Scale Using VAS
Time frame: 1 hour post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- 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.
Giorgio Veneziano, MD principal investigator
Nationwide Children's Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, run by Giorgio Veneziano.
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 3 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 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
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 6 Mar 2019). 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?
Concentration of Local Anesthetic Injected for Femoral Nerve Block (time frame: length of surgery). The study lists 4 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 6 Mar 2019.