Ankle FracturePhase 3NCT02480621
Liposomal Bupivacaine With Bupivacaine in Ankle Fracture Open Reduction Internal Fixation (ORIF)
A Phase 3 study testing Liposomal Bupivacaine with Bupivacaine in people with Ankle Fracture, run by Jamaica Hospital Medical Center at 1 site in United States.
Trial summary
This study is a randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankle Fracture
- What is being tested?
- Liposomal Bupivacaine with Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 31 Aug 2016
- Phase
- Phase 3
- 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
- Patients at least 18 years old.
- Male or Female
- All racial and ethnic groups
- Fractures and fracture/dislocations of the ankle
- Patients who opt for surgical treatment of their fractures.
- Patients who consent to be randomized.
- Patients who are willing to follow-up for a minimum of 52 weeks.
Who cannot join
- Patients younger than 18 years old
- Patients who are on chronic opioids
- Patients who abuse opioids
- Patients who are unwilling to follow-up for a minimum of 52 weeks
- Neurologic condition that could interfere with pain sensation
Trial locations and contacts
1 site in 1 country.
United States1 site
Jamaica Hospital Medical Center
Jamaica, New York, 11418
About this study
Official title: The Impact of Liposomal Bupivicaine on Post-Operative Pain in Orthopaedic Trauma Surgery: A Double-Blind Prospective Randomized Control Trial
This study is a randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively.
Read the detailed description
This study is a prospective, randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively. Patients are to remain blinded to the treatment arm. The surgeon is non-blinded and administers the bupivacaine solution locally, intra-operatively.
Patients pain scores and pain medication usage is documented. A trained research coordinator contacts each patient at 24, 48, and 72 hours post-operatively to assess pain levels on a visual analog scale (VAS) and pain medications taken. Patients return for followup at standard intervals of 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operatively to assess healing and functional outcomes. Patients are queried as to satisfaction with pain control at 2 weeks post-operatively. The study will compare outcomes including pain levels, pain medications taken, operating room (OR) and post-anesthesia care unit (PACU) times, length of stay (LOS), satisfaction with pain control, clinical outcomes, and complication rates.
- Conditions
- Ankle Fracture
- Being tested
- Liposomal Bupivacaine with Bupivacaine
- Medical subject headings
- Ankle Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Bupivacaine with BupivacaineDrug
Also called Exparel
Pain medications injected locally during surgery around affected ankle.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle. |
| Liposomal Bupivacaine with Bupivacaine | Experimental | Intra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle. Receives: Drug: Liposomal Bupivacaine with Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Levels on a Visual Analog Scale ( VAS)
A Visual Analog Scale (VAS) ranging from 0 to 10 in increments of 1 was used to both qualitatively and quantitatively assess the level and severity of pain during the time points ranging from the immediate post-operative period through 72 hours post-operative. Each number on the scale is accompanied by a visual facial expression that indicates the level of pain, discomfort, and distress appropriate to the number on the scale. The more severe the level of pain, the higher the corresponding number and more distressing the accompanying facial expression. A VAS score of 0 indicates no active pain level and is accompanied by a pleasantly smiling face whereas a VAS score of 10 indicates the most severe active pain level and is accompanied by a visibly-distraught face that is frowning, grimacing, and sweating. The combination of facial expressions and numbers is supposed to provide a language-independent, validated means of assessing pain levels.
Measured: Immediate post-operative period until 72 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2015 (estimated)
- Study startDec 2014
- Primary completion30 Jun 2016
- Study completion31 Aug 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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ankle FractureStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jamaica Hospital Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roy Davidovitch, M.D., Jamaica Hospital Medical Center
- Investigators
- Roy Davidovitch, MD, Principal investigator, Jamaica Hospital Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480621
- Sponsor's protocol ID
- 623477-4
- Status last verified
- Sep 2017
- First submitted
- 22 Jun 2015
- Last updated
- 20 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Owen RT. Bupivacaine liposome injectable suspension: a new approach to postsurgical pain. Drugs Today (Barc). 2013 Aug;49(8):475-82. doi: 10.1358/dot.2013.49.8.2006992.
PubMed 23977664Joshi GP, Cushner FD, Barrington JW, Lombardi AV Jr, Long WJ, Springer BD, Stulberg BN. Techniques for periarticular infiltration with liposomal bupivacaine for the management of pain after hip and knee arthroplasty: a consensus recommendation. J Surg Orthop Adv. 2015 Spring;24(1):27-35.
PubMed 25830260Lonner JH, Scuderi GR, Lieberman JR. Potential utility of liposome bupivacaine in orthopedic surgery. Am J Orthop (Belle Mead NJ). 2015 Mar;44(3):111-7.
PubMed 25750943Robbins J, Green CL, Parekh SG. Liposomal bupivacaine in forefoot surgery. Foot Ankle Int. 2015 May;36(5):503-7. doi: 10.1177/1071100714568664. Epub 2015 Jan 22.
PubMed 25614060
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Liposomal Bupivicaine on Post-Operative Pain in Orthopaedic Trauma Surgery: A Double-Blind Prospective Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02480621
- Acronym / sponsor ID
- 623477-4
- Conditions
- Ankle Fracture
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Jamaica Hospital Medical CenterUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 24 Jun 2015 (estimated)
- Results
- Posted 20 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively.
Detailed description
This study is a prospective, randomized controlled trial assessing pain control in ankle fractures repaired with open reduction and internal fixation. Patients are consented and enrolled pre-operatively, and randomized to either control or liposomal bupivacaine with bupivacaine administered intra-operatively. Patients are to remain blinded to the treatment arm. The surgeon is non-blinded and administers the bupivacaine solution locally, intra-operatively.
Patients pain scores and pain medication usage is documented. A trained research coordinator contacts each patient at 24, 48, and 72 hours post-operatively to assess pain levels on a visual analog scale (VAS) and pain medications taken. Patients return for followup at standard intervals of 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operatively to assess healing and functional outcomes. Patients are queried as to satisfaction with pain control at 2 weeks post-operatively. The study will compare outcomes including pain levels, pain medications taken, operating room (OR) and post-anesthesia care unit (PACU) times, length of stay (LOS), satisfaction with pain control, clinical outcomes, and complication rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care: Open Reduction Internal Fixation with no injection of pain medications around the affected ankle. |
| Liposomal Bupivacaine with Bupivacaine | Experimental | Drug: Liposomal Bupivacaine with BupivacaineIntra-operatively, patients receive a local injection of liposomal bupivacaine with bupivacaine around the affected ankle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients at least 18 years old.
- Male or Female
- All racial and ethnic groups
- Fractures and fracture/dislocations of the ankle
- Patients who opt for surgical treatment of their fractures.
Key exclusion criteria (5 listed)
- Patients younger than 18 years old
- Patients who are on chronic opioids
- Patients who abuse opioids
- Patients who are unwilling to follow-up for a minimum of 52 weeks
- Neurologic condition that could interfere with pain sensation
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 |
|---|---|---|
| Liposomal Bupivacaine with BupivacaineAlso: ExparelPain medications injected locally during surgery around affected ankle. | Drug | Liposomal Bupivacaine with Bupivacaine |
Primary outcome
Pain Levels on a Visual Analog Scale ( VAS)
Time frame: Immediate post-operative period until 72 hours post-operatively
A Visual Analog Scale (VAS) ranging from 0 to 10 in increments of 1 was used to both qualitatively and quantitatively assess the level and severity of pain during the time points ranging from the immediate post-operative period through 72 hours post-operative. Each number on the scale is accompanied by a visual facial expression that indicates the level of pain, discomfort, and distress appropriate to the number on the scale. The more severe the level of pain, the higher the corresponding number and more distressing the accompanying facial expression. A VAS score of 0 indicates no active pain level and is accompanied by a pleasantly smiling face whereas a VAS score of 10 indicates the most severe active pain level and is accompanied by a visibly-distraught face that is frowning, grimacing, and sweating. The combination of facial expressions and numbers is supposed to provide a language-independent, validated means of assessing pain levels.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23977664Owen RT. Bupivacaine liposome injectable suspension: a new approach to postsurgical pain. Drugs Today (Barc). 2013 Aug;49(8):475-82. doi: 10.1358/dot.2013.49.8.2006992.
- Background: PubMed 25830260Joshi GP, Cushner FD, Barrington JW, Lombardi AV Jr, Long WJ, Springer BD, Stulberg BN. Techniques for periarticular infiltration with liposomal bupivacaine for the management of pain after hip and knee arthroplasty: a consensus recommendation. J Surg Orthop Adv. 2015 Spring;24(1):27-35.
- Background: PubMed 25750943Lonner JH, Scuderi GR, Lieberman JR. Potential utility of liposome bupivacaine in orthopedic surgery. Am J Orthop (Belle Mead NJ). 2015 Mar;44(3):111-7.
- Background: PubMed 25614060Robbins J, Green CL, Parekh SG. Liposomal bupivacaine in forefoot surgery. Foot Ankle Int. 2015 May;36(5):503-7. doi: 10.1177/1071100714568664. Epub 2015 Jan 22.
Related trials for Ankle Fracture
Not yet recruiting
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle Fractures, Syndesmotic Injury
Recruiting
Investigating Auto Adjusting Dynamic AFO
Lower Limb; Fusion, Congenital, Lower Limb Fracture
Recruiting
Lateral Ankle Treatment
Avulsion Fracture
RecruitingObservational study
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
Syndesmotic Injury, Trimalleolar Fracture
Not yet recruiting
Outpatient Floor Pedal Bike Utilization
Femur Fracture, Tibia Fracture
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.
Roy Davidovitch, MD principal investigator
Jamaica Hospital Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liposomal Bupivacaine with Bupivacaine in people with Ankle Fracture, run by Jamaica Hospital Medical Center 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 7 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 20 Oct 2017. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 20 Oct 2017). 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?
Pain Levels on a Visual Analog Scale ( VAS) (time frame: Immediate post-operative period until 72 hours post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02480621, which also lists 4 linked publications.
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 20 Oct 2017.