Ankle FracturesEarly Phase 1NCT05019638
Local Multimodal Injection Versus Regional Anesthesia in Controlling Pain for Treating Rotational Ankle Fractures
A Early Phase 1 study testing Regional anesthesia group and Local multimodal analgesia group in people with Ankle Fractures, run by University of Utah at 2 sites in United States.
Trial summary
The investigators plan to evaluate the efficacy in reducing post-operative pain between local multimodal analgesia as compared to regional anesthesia in rotational ankle fractures. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ankle Fractures
- What is being tested?
- Regional anesthesia group and Local multimodal analgesia group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Mar 2021to May 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- isolated rotational ankle fracture
- operative intervention needed
- English or Spanish speaking
- provide informed consent
- able to communicate with the research team via email or phone
Who cannot join
- sustain concomitant head injury
- additional lower extremity fracture(s)
- open fracture
- prior drug dependency
- allergies to any of the ingredients in the local injection or peripheral nerve block
- any history of stroke
- major neurological deficit
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Utah Orthopaedic Center
Salt Lake City, Utah, 84108
University of Utah Orthopedics
Salt Lake City, Utah, 84112
About this study
Official title: Evaluating the Effectiveness of Local Multimodal Injection in Controlling Pain, Limiting Complications, and Reducing Cost as Compared to Regional Anesthesia for Treating Rotational Ankle Fractures.
The investigators plan to evaluate the efficacy in reducing post-operative pain between local multimodal analgesia as compared to regional anesthesia in rotational ankle fractures.
Read the detailed description
Pain control is a chief domain in patient-centered care and may play a key role in outcome-driven reimbursement as a focus on payment strategies shifts in this direction. The Center for Medicaid and Medicare Services has developed the Total Performance Score for Hospitals, which is factored into the reimbursement for provided services. Pain Management is one of the main contributors to the score. Moreover, pain control has been shown to improve patient satisfaction, which is of increasing importance in medicine today.
The United States is in the midst of an opioid epidemic where we consume 80% of the world's narcotics with only 5% of the world's population. Prescription opioids may play a major role in up to 40% of opioid overdose deaths. Orthopedic surgeons are the top prescribing surgical specialists and the fourth-largest overall prescriber of narcotic medication, representing 7.7% of total opioid prescriptions. Given the magnitude and implications of the opioid epidemic, orthopedic surgeons have been tasked with delivering adequate pain control while avoiding excessive narcotic prescriptions that can lead to opioid addiction and opioid-related deaths.
Regional anesthesia has been extensively studied for operatively managed rotational ankle fractures. Foot and ankle surgery patients receiving regional anesthesia have been reported to have lower pain scores and less narcotic usage for up to 8 weeks post-operatively. In a prospective cohort study of ankle fracture patients, Investigators have demonstrated improved pain management in patients who received single-shot regional anesthesia as compared to control patients. In a blinded, prospective, randomized controlled trial, it was reported lower pain scores and longer analgesia in patients receiving peripheral nerve block as compared to control patients.
Local multimodal analgesia has been used extensively in the setting of total knee arthroplasty. Numerous studies have investigated the effect of these injections and shown a decrease in perioperative pain and the use of perioperative narcotics. A team of investigators looked at multimodal analgesia injections in femur fractures of all kinds. They found that in patients receiving the injection, their pain was decreased over the first postoperative day along with consuming fewer narcotics over the same time frame. Unfortunately, the randomization in this study resulted in an unequal distribution of injuries that may have biased the results. It was noted, "further investigations are required to establish the efficacy of this multimodal protocol for the individual surgical procedures considered."
Several aspects of the proposed study are innovative and the results of which will provide evidence for significant change. The proposed studies focuses on one of the most common skeletal injuries treated with surgical intervention by orthopaedic surgeons. These investigators are thus focusing on an area with widespread implications where a small change in practice could result in extensive change through the system. The overarching goal for this investigation is to optimize postoperative pain control delivery while limiting narcotic medication consumption.
There are currently no studies that compare the effectiveness and cost between local multimodal analgesia and regional anesthesia as it relates to rotational ankle fractures. Despite extensive use in arthroplasty, local multimodal analgesia has limited usage in the setting of fracture or acute injury. This represents a significant area of innovation and growth in the realm of orthopaedic traumatology. Given the commonplace nature of ankle fractures and the ability to perform regional anesthesia given the lack of compartment syndrome risk, these injuries represent the ideal candidate to explore a new mode of postoperative analgesia. Additionally, incorporating an anti-inflammatory medication into the local multimodal injection cocktail is novel. While a stigma associated with anti-inflammatory medications and impaired bone healing exist, single usage should be relatively low risk while providing significant local pain relief. The ability of local multimodal analgesia to provide similar pain control as regional anesthesia would expand the possibility of using local multimodal analgesia in locations that do not have an appropriately trained anesthesiologist for regional anesthesia. It may also improve the workflow and open the possibility of investigation as it relates to other common fractures.
The hypothesis is that ankle fracture patients with post-operative local multimodal analgesia will have similar Visual Analog Scale (VAS) pain scores as patients with post-operative regional anesthesia at 24 hours post-surgery. Secondary analyses will compare VAS pain scores at 1, 2, 4, and 8 hours post-operatively in addition to post-operative narcotic usage between the two groups.
- Conditions
- Ankle Fractures
- Being tested
- Regional anesthesia group, Local multimodal analgesia group
- Keywords
- rotational ankle fractures, regional anesthesia, local multimodal injection, pain
- Medical subject headings
- Ankle Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regional anesthesia groupDrug
Also called Marcaine (bupivacaine), Adrenalin (epinephrine)
bupivacaine 0.25% with epinephrine 1:400,000.
Local multimodal analgesia groupDrug
Also called MS Contin, Astramorph, Depodur, Duramorph, Infumorph, Kadian, MorphaBond, Arymo ER (morphine), Adrenalin (epinephrine), Toradol (ketorolac), Marcaine (bupivacaine)
5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Regional anesthesia group | Active comparator | Standard single-shot anesthesia consists of bupivacaine 0.25% with epinephrine 1:400,000. Receives: Drug: Regional anesthesia group |
| Local multimodal analgesia group | Experimental | Local multimodal analgesia composition will include 5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine. Receives: Drug: Local multimodal analgesia group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: Pre-operative
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: 1-hour post-operative
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: 2-hour post -operative
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: 4-hour post-operative
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: 8-hour post-operative
Visual Analog Scale (VAS) pain
VAS pain score (0 no pain - 10 severe pain)
Measured: 24-hour post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start15 Mar 2021
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle FracturesStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Justin Haller, University of Utah
- Investigators
- Justin Haller, MD, Principal investigator, University of Utah Orthopaedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019638
- Sponsor's protocol ID
- 137271
- Status last verified
- Apr 2026
- First submitted
- 19 Jul 2021
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Local Multimodal Injection in Controlling Pain, Limiting Complications, and Reducing Cost as Compared to Regional Anesthesia for Treating Rotational Ankle Fractures.
- ClinicalTrials.gov ID
- NCT05019638
- Acronym / sponsor ID
- 137271
- Conditions
- Ankle Fractures
- Keywords
- rotational ankle fractures, regional anesthesia, local multimodal injection, pain
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 25 Aug 2021 (actual)
- 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.
The investigators plan to evaluate the efficacy in reducing post-operative pain between local multimodal analgesia as compared to regional anesthesia in rotational ankle fractures.
Detailed description
Pain control is a chief domain in patient-centered care and may play a key role in outcome-driven reimbursement as a focus on payment strategies shifts in this direction. The Center for Medicaid and Medicare Services has developed the Total Performance Score for Hospitals, which is factored into the reimbursement for provided services. Pain Management is one of the main contributors to the score. Moreover, pain control has been shown to improve patient satisfaction, which is of increasing importance in medicine today.
The United States is in the midst of an opioid epidemic where we consume 80% of the world's narcotics with only 5% of the world's population. Prescription opioids may play a major role in up to 40% of opioid overdose deaths. Orthopedic surgeons are the top prescribing surgical specialists and the fourth-largest overall prescriber of narcotic medication, representing 7.7% of total opioid prescriptions. Given the magnitude and implications of the opioid epidemic, orthopedic surgeons have been tasked with delivering adequate pain control while avoiding excessive narcotic prescriptions that can lead to opioid addiction and opioid-related deaths.
Regional anesthesia has been extensively studied for operatively managed rotational ankle fractures. Foot and ankle surgery patients receiving regional anesthesia have been reported to have lower pain scores and less narcotic usage for up to 8 weeks post-operatively. In a prospective cohort study of ankle fracture patients, Investigators have demonstrated improved pain management in patients who received single-shot regional anesthesia as compared to control patients. In a blinded, prospective, randomized controlled trial, it was reported lower pain scores and longer analgesia in patients receiving peripheral nerve block as compared to control patients.
Local multimodal analgesia has been used extensively in the setting of total knee arthroplasty. Numerous studies have investigated the effect of these injections and shown a decrease in perioperative pain and the use of perioperative narcotics. A team of investigators looked at multimodal analgesia injections in femur fractures of all kinds. They found that in patients receiving the injection, their pain was decreased over the first postoperative day along with consuming fewer narcotics over the same time frame. Unfortunately, the randomization in this study resulted in an unequal distribution of injuries that may have biased the results. It was noted, "further investigations are required to establish the efficacy of this multimodal protocol for the individual surgical procedures considered."
Several aspects of the proposed study are innovative and the results of which will provide evidence for significant change. The proposed studies focuses on one of the most common skeletal injuries treated with surgical intervention by orthopaedic surgeons. These investigators are thus focusing on an area with widespread implications where a small change in practice could result in extensive change through the system. The overarching goal for this investigation is to optimize postoperative pain control delivery while limiting narcotic medication consumption.
There are currently no studies that compare the effectiveness and cost between local multimodal analgesia and regional anesthesia as it relates to rotational ankle fractures. Despite extensive use in arthroplasty, local multimodal analgesia has limited usage in the setting of fracture or acute injury. This represents a significant area of innovation and growth in the realm of orthopaedic traumatology. Given the commonplace nature of ankle fractures and the ability to perform regional anesthesia given the lack of compartment syndrome risk, these injuries represent the ideal candidate to explore a new mode of postoperative analgesia. Additionally, incorporating an anti-inflammatory medication into the local multimodal injection cocktail is novel. While a stigma associated with anti-inflammatory medications and impaired bone healing exist, single usage should be relatively low risk while providing significant local pain relief. The ability of local multimodal analgesia to provide similar pain control as regional anesthesia would expand the possibility of using local multimodal analgesia in locations that do not have an appropriately trained anesthesiologist for regional anesthesia. It may also improve the workflow and open the possibility of investigation as it relates to other common fractures.
The hypothesis is that ankle fracture patients with post-operative local multimodal analgesia will have similar Visual Analog Scale (VAS) pain scores as patients with post-operative regional anesthesia at 24 hours post-surgery. Secondary analyses will compare VAS pain scores at 1, 2, 4, and 8 hours post-operatively in addition to post-operative narcotic usage between the two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regional anesthesia group | Active comparator | Drug: Regional anesthesia groupStandard single-shot anesthesia consists of bupivacaine 0.25% with epinephrine 1:400,000. |
| Local multimodal analgesia group | Experimental | Drug: Local multimodal analgesia groupLocal multimodal analgesia composition will include 5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- isolated rotational ankle fracture
- operative intervention needed
- English or Spanish speaking
- provide informed consent
- able to communicate with the research team via email or phone
Key exclusion criteria (7 listed)
- sustain concomitant head injury
- additional lower extremity fracture(s)
- open fracture
- prior drug dependency
- allergies to any of the ingredients in the local injection or peripheral nerve block
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 |
|---|---|---|
| Regional anesthesia groupAlso: Marcaine (bupivacaine), Adrenalin (epinephrine)bupivacaine 0.25% with epinephrine 1:400,000. | Drug | Regional anesthesia group |
| Local multimodal analgesia groupAlso: MS Contin, Astramorph, Depodur, Duramorph, Infumorph, Kadian, MorphaBond, Arymo ER (morphine), Adrenalin (epinephrine), Toradol (ketorolac), Marcaine (bupivacaine)5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine. | Drug | Local multimodal analgesia group |
Primary outcome
Visual Analog Scale (VAS) pain
Time frame: Pre-operative
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: 1-hour post-operative
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: 2-hour post -operative
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: 4-hour post-operative
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: 8-hour post-operative
VAS pain score (0 no pain - 10 severe pain)
Visual Analog Scale (VAS) pain
Time frame: 24-hour post-operative
VAS pain score (0 no pain - 10 severe pain)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Justin Haller, MD principal investigator
University of Utah Orthopaedics
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Regional anesthesia group and Local multimodal analgesia group in people with Ankle Fractures, run by University of Utah at 2 sites 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 5 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Visual Analog Scale (VAS) pain (time frame: Pre-operative). The study lists 6 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 29 Apr 2026.