Ankle ArthrodesisPhase 4NCT02586077
Foot and Ankle Clinic Application for Liposomal Related Anesthetic
A Phase 4 study testing Exparel in people with Ankle Arthrodesis and Hindfoot Arthrodesis, run by OrthoCarolina Research Institute, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to review the use of surgeon applied liposomal release anesthetic (Exparel) for post operative analgesia. Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post operative analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Arthrodesis, Hindfoot Arthrodesis, Tibitalocalceal Arthrodesis
- What is being tested?
- Exparel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2014to 15 Nov 2016
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient scheduled for ankle arthrodesis, a tibiotalocalcaneal arthrodesis, hindfoot arthrodesis including subtalar, double, triple, or isolated talonavicular arthrodesis
- Patients over the age of 18
- The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study
Who cannot join
- < 18 years of age
- Patients with a history of infection
- Patients diagnosed with neuropathy or any form of numbness or loss of feeling in the arms or legs due to damaged nerves
- Patients having surgery on both feet at the same time
- Patients having any other different type of foot and ankle surgery
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to review the use of surgeon applied liposomal release anesthetic (Exparel) for post operative analgesia.
Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by the use of this modality.
- Being tested
- Exparel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
| Study group | Role | What they receive |
|---|---|---|
| Exparel | Experimental | Patients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case. Receives: Drug: Exparel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Narcotic Use
Total morphine milligram equivalence dosing of all narcotic pain medications administered between the surgery and the third post-operative day.
Measured: Surgery to post operative day 3
Secondary outcomes (4)
Visual Analog Scale of Pain (0-10)
Visual Analog Scale (VAS) of pain (0-10); with 10 indicating the greatest amount of pain. Post anesthesia care unit admission, post anesthesia care unit discharge, day of surgery, post operative day 1, post operative day 2, post operative day 3
Measured: Post anesthesia care unit admission to post operative day 3
Anti-emetic Use
Anti-emetic use (as a binary yes/no) between the admission in the post anesthesia care unit through hospital discharge (i.e. if a patient took an anti-emetic at any point duration the time frame the patient was a yes; if the patient did not take an anti-emetic during the time frame the patient was a no).
Measured: After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3)
Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief
Measured at hospital discharge (on post operative day 3). Measured on a scale of 1-5, with 5 being the most satisfaction
Measured: Measured at hospital discharge (on post operative day 3)
Number of Patients With Post-operative Complications
Any complications occurring between the day of surgery and the first scheduled appointment at our clinic after the surgery.
Measured: After surgery to the first scheduled clinic visit, usually 14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study start1 Feb 2014
- Primary completion30 Jun 2016
- Study completion15 Nov 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 Ankle ArthrodesisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- OrthoCarolina Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Sponsor
- Investigators
- Susan M Odum, PhD, Study director, OrthoCarolina Research InstituteBruce Cohen, MD, Principal investigator, OrthoCarolina Foot & Ankle Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586077
- Sponsor's protocol ID
- 12-13-12E
- Status last verified
- Oct 2020
- First submitted
- 1 Jun 2015
- Last updated
- 29 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Foot and Ankle Clinic Application for Liposomal Related Anesthetic
- ClinicalTrials.gov ID
- NCT02586077
- Acronym / sponsor ID
- 12-13-12E
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- OrthoCarolina Research Institute, Inc.University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- 1 Feb 2014
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 15 Nov 2016 (actual)
- First posted
- 26 Oct 2015 (estimated)
- Results
- Posted 29 Oct 2020
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 review the use of surgeon applied liposomal release anesthetic (Exparel) for post operative analgesia.
Hypothesis: Surgeon applied use of liposomal related anesthetic provides excellent post operative analgesia. Immediated and 72 hour narcotic use will be significantly impacted by the use of this modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exparel | Experimental | Drug: ExparelPatients will receive a single shot popliteal block (standard of care) and then undergo their standardized procedure. Patients will then receive 20cc Exparel and 10cc of normal saline at the conclusion of the case. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Any patient scheduled for ankle arthrodesis, a tibiotalocalcaneal arthrodesis, hindfoot arthrodesis including subtalar, double, triple, or isolated talonavicular arthrodesis
- Patients over the age of 18
- The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study
Key exclusion criteria (5 listed)
- < 18 years of age
- Patients with a history of infection
- Patients diagnosed with neuropathy or any form of numbness or loss of feeling in the arms or legs due to damaged nerves
- Patients having surgery on both feet at the same time
- Patients having any other different type of foot and ankle surgery
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 |
|---|---|---|
| Exparel | Drug | Exparel |
Primary outcome
Amount of Narcotic Use
Time frame: Surgery to post operative day 3
Total morphine milligram equivalence dosing of all narcotic pain medications administered between the surgery and the third post-operative day.
4 secondary outcomes
Visual Analog Scale of Pain (0-10)
Time frame: Post anesthesia care unit admission to post operative day 3
Anti-emetic Use
Time frame: After surgery through discharge from hospital, usually 72 hours after surgery (on post operative day 3)
Patient Satisfaction Questionnaire Regarding Post Surgical Pain Relief
Time frame: Measured at hospital discharge (on post operative day 3)
Number of Patients With Post-operative Complications
Time frame: After surgery to the first scheduled clinic visit, usually 14 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- 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.
Susan M Odum, PhD study director
OrthoCarolina Research Institute
Bruce Cohen, MD principal investigator
OrthoCarolina Foot & Ankle Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exparel in people with Ankle Arthrodesis and Hindfoot Arthrodesis, run by OrthoCarolina Research Institute, Inc. 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 3 inclusion and 5 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 29 Oct 2020. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Oct 2020). 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?
Amount of Narcotic Use (time frame: Surgery to post operative day 3). 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 29 Oct 2020.