Total Ankle ArthroplastyPhase 3NCT07212114
Efficacy of EXPAREL vs. Bupivacaine
A Phase 3 study testing EXPAREL, 0.25% bupivacaine (HCl): 50 ml and 0.25% bupivacaine (HCl): 30 ml in people with Total Ankle Arthroplasty and Postsurgical Analgesia, run by Emory University at 1 site in United States.
Trial summary
The goal of this clinical study is to learn about pain management strategies in subjects undergoing total ankle replacement. arthroplasty surgery The primary objective is to compare the magnitude of the analgesic effect following a single dose injection of EXPAREL vs. 0.25% bupivacaine (HCl). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Ankle Arthroplasty, Postsurgical Analgesia
- What is being tested?
- EXPAREL, 0.25% bupivacaine (HCl): 50 ml and 0.25% bupivacaine (HCl): 30 ml
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2025to Aug 2029
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indicated to undergo unilateral total ankle arthroplasty
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments
- Body Mass Index (BMI) ≥18 and ≤40 kg/m2
Who cannot join
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
- Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post-dosing period for pain, and which, in the Investigator's opinion, may confound the post-dosing assessments
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
- Currently pregnant, nursing, or planning to become pregnant during the study
- History of contralateral ankle arthroplasty within 1 year
Show all 14Show fewer
- Subjects that require ankle arthroplasty due to failed prior ankle arthrodesis
- Subjects with avascular necrosis of the talus
- Subjects undergoing revision total ankle arthroplasty
- Clinically significant medical disease that, in the opinion of the Investigator, would make participation in a clinical study inappropriate. This includes diabetic neuropathy, coagulation or bleeding disorders, severe peripheral vascular disease, renal insufficiency, hepatic dysfunction or other conditions that would constitute a contraindication to participation in the study
- Chronic opioid use within 30 days before randomization (average ≥30 oral morphine equivalents/day
- Prisoners
- Cognitive impairment or impaired decision-making capacity
- Inability to communicate in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University Orthopaedic Hospital Musculoskeletal Institute (MSK)
Atlanta, Georgia, 30329
Sameh Labid, MD, FAOA, 404-778-4398, slabib@emory.edu
About this study
Official title: A Randomized, Double-blind, Active Controlled, Single-center Study to Evaluate the Efficacy of EXPAREL vs. Bupivacaine HCl Administered as Combined Sciatic (in the Popliteal Fossa) and Saphenous (in the Adductor Canal) Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Total Ankle Arthroplasty
The goal of this clinical study is to learn about pain management strategies in subjects undergoing total ankle replacement. arthroplasty surgery The primary objective is to compare the magnitude of the analgesic effect following a single dose injection of EXPAREL vs. 0.25% bupivacaine (HCl).
Secondary objectives are to:
Read more
Compare the total opioid consumption (in oral morphine equivalents) from 0 to 96 hours following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl
- Compare the time to first opioid consumption following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl
- Assess the safety of EXPAREL vs. 0.25% bupivacaine HCl
- Evaluate subject satisfaction with pain management following a single-dose injection of EXPAREL vs. 0.25% bupivacaine hydrochloride (HCl)
- Compare clinical performance from Preoperative status to 3- and 12- months postoperatively
Read the detailed description
EXPAREL® is a long-acting local anesthetic specifically developed to provide extended postsurgical pain relief from a single-dose administration, thereby reducing or eliminating the need for indwelling catheters and minimizing reliance on supplemental opioid medications. It is currently indicated for single-dose infiltration to produce local analgesia in patients aged 6 years and older, as well as for regional analgesia via interscalene brachial plexus, sciatic (in the popliteal fossa), and adductor canal nerve blocks in adults. Pain following surgery is common, often peaking in the initial postoperative days, and if inadequately managed, it can delay healing, impair mobilization, prolong hospital stays, and increase the risk of complications and healthcare costs. Despite the prevalence of multimodal analgesic strategies-including the use of local anesthetics and systemic opioids-opioids remain a mainstay for moderate to severe postsurgical pain. However, their use is often limited by adverse effects such as respiratory depression, nausea, vomiting, pruritus, constipation, somnolence, and urinary retention. These complications not only reduce patient satisfaction and recovery but also increase medical intervention and resource use, making opioid-sparing alternatives clinically and economically attractive.
EXPAREL addresses this need by leveraging a proprietary multivesicular liposome (pMVL) drug delivery system that encapsulates bupivacaine at a concentration of 13.3 mg/mL within microscopic spherical vesicles. These vesicles-composed of naturally occurring or bioanalogous lipids-release bupivacaine gradually over time through lipid membrane reorganization and diffusion, thereby extending its duration of action well beyond the 6-8 hours typical of conventional bupivacaine formulations. The liposomal technology used in EXPAREL is based on the same pMVL platform found in the FDA-approved product DepoCyt®, though EXPAREL's lipid formulation has been modified for local anesthetic use. Since its initial FDA approval in 2011 for surgical site infiltration and the subsequent expansion of its indications in 2018 to include various nerve blocks, EXPAREL has been administered to approximately 14 million patients in the U.S., highlighting its growing adoption in clinical practice.
The rationale for the current study stems from the need to optimize postsurgical pain control in patients undergoing total ankle arthroplasty, a procedure associated with significant postoperative pain. This randomized, double-blind, active-controlled, single-center trial will evaluate the efficacy of EXPAREL when used in combination with bupivacaine HCl as part of a combined sciatic (popliteal fossa) and saphenous (adductor canal) nerve block regimen. Specifically, the intervention group will receive 20 mL EXPAREL (266 mg) admixed with 20 mL of 0.25% bupivacaine HCl (50 mg), while the control group will receive 40 mL of 0.25% bupivacaine HCl (100 mg), with each agent administered in equal volumes to the respective nerve sites. The objective is to determine whether the EXPAREL-based regimen provides more effective and longer-lasting analgesia compared to bupivacaine HCl alone, thereby enhancing recovery, reducing opioid consumption, and improving overall patient outcomes in a high-pain surgical population.
- Conditions
- Total Ankle Arthroplasty, Postsurgical Analgesia
- Being tested
- EXPAREL, 0.25% bupivacaine (HCl): 50 ml, 0.25% bupivacaine (HCl): 30 ml
- Keywords
- Pain management, Postsurgical Analgesia, Bupivacaine, EXPAREL
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXPARELDrug
Also called bupivacaine liposome injectable suspension
EXPAREL (bupivacaine liposome injectable suspension) is formulated as a sterile, non-pyrogenic, white to off-white, preservative-free homogenous suspension of bupivacaine encapsulated into multivesicular liposomes (pMVL drug delivery system). For this study, EXPAREL will be provided in 20 mL (266 mg) EXPAREL single-use, clear glass vials.
0.25% bupivacaine (HCl): 50 mlDrug
The reference product is 50 mL (100 mg) 0.25% bupivacaine HCl administered via a combined sciatic (in the popliteal fossa) and saphenous nerve block (in the adductor canal)
0.25% bupivacaine (HCl): 30 mlDrug
EXPAREL admixed with 30 mL (75 mg) 0.25% bupivacaine HCl
| Study group | Role | What they receive |
|---|---|---|
| Admix | Experimental | EXPAREL admixed with 0.25% bupivacaine HCl Total volume (50 mL) will be split such that 30 mL will be administered as the sciatic nerve block (in the popliteal fossa) and 20 mL will be administered as the saphenous nerve block (in the adductor canal) Receives: Drug: EXPAREL; Drug: 0.25% bupivacaine (HCl): 30 ml |
| Reference | Experimental | Bupivacaine HCl arm Total volume (50 mL) will be split such that 30 mL will be administered as the sciatic nerve block (in the popliteal fossa) and 20 mL will be administered as the saphenous nerve block (in the adductor canal) Receives: Drug: 0.25% bupivacaine (HCl): 50 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnitude of the analgesic effect
To measure this, the Area under the curve (AUC) of the Numeric Rating Scale (NRS) for both groups will be compared.
The subjects will be asked to rate their worst or average pain on a scale of 0 (no pain) - 10 (worst possible pain) on numerous time points, starting upon arrival in the Post-Anesthesia Care Unit (PACU)
Measured: Perioperative (Upon arrival in the PACU (±5 min), Postoperative (At PACU discharge (±5 min)), Every 6 hours from the end of surgery until health care facility discharge up to 96h
Secondary outcomes (9)
Total opioid consumption
Compare the total opioid consumption (in oral morphine equivalents) from 0 to 96 hours following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl
Measured: Baseline (Hour 0), 96 hours post surgery
Time to first opioid consumption
Compare the time to first opioid consumption in oral morphine equivalents (OMED) following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl
Measured: Baseline (Hour 0), 96 hours post surgery
Patient safety
Safety of EXPAREL vs. 0.25% bupivacaine HCl will be assessed by the Incidence of treatment-emergent Adverse Events and Serious AEs from the start of the nerve block procedure through Post op day (POD) 14
Measured: Baseline (Hour 0), Day 14 post op
Subject satisfaction
Subject satisfaction with pain management following the intervention in both groups will be assessed using a Subject Satisfaction Questionnaire. This consists of a single question asking participants to rate their satisfaction with pain management outcomes on a scale from 0 to 10, where 0 indicates 'extremely dissatisfied' and 10 indicates 'extremely satisfied
Measured: Within 96 hours post op
Pain intensity: Numeric Rating Scale (NRS) Short term
Pain intensity will be measured using the 11-point NRS. The subject will be asked to rate their worst or average pain on a scale of 0 (no pain) to 10 (worst possible pain) in the operative ankle.
This will be measured up to 96 hours post op.
Measured: Every 6 hours from the end of surgery until health care facility discharge up to 96h
Pain intensity: Numeric Rating Scale (NRS) : post discharge
Pain intensity will be measured using the 11-point NRS. The subject will be asked to rate their worst or average pain on a scale of 0 (no pain) to 10 (worst possible pain) in the operative ankle.
Twice daily from the day 1 of discharge up to Day 7 post-discharge
Measured: Twice daily from the day of discharge upto Day 7 days post discharge
Pain intensity: Numeric Rating Scale (NRS): Long term
Pain intensity will be measured using the 11-point NRS. The subject will be asked to rate their worst or average pain on a scale of 0 (no pain) to 10 (worst possible pain) in the operative ankle.
Twice daily from day 7 of discharge up to 14 days post-discharge
Measured: Twice daily from the day 7 of discharge upto Day 14 post discharge
Clinical Performance: SF-12
Scoring the SF-12 Health Survey involves calculating two key summary scores: the Physical Component Summary (PCS-12) and the Mental Component Summary (MCS-12). These scores reflect a person's overall physical and mental health status, respectively, and are derived from responses to 12 questions covering eight health domains.
Standardized Scores: Both PCS-12 and MCS-12 are scored on a scale where:
- A score above 50 indicates better-than-average health.
- A score below 50 suggests worse-than-average health.
Measured: Preoperative, 3 months post op, 12 months post op
Clinical Performance: Ankle Osteoarthritis Score
The Ankle Osteoarthritis Score (AOS) is a patient-reported outcome measure designed to assess pain and functional limitations caused by ankle osteoarthritis. It uses a series of visual analogue scales (VAS) where patients rate their pain and difficulty performing daily activities over the past week.
Pain Subscale: Assesses ankle pain in various situations (e.g., walking barefoot, standing with shoes, end of day).
Disability Subscale: Evaluates difficulty with activities like walking on uneven ground, climbing stairs, or running.
Each item is rated on a 100 mm VAS line.
- Scores range from 0 (no pain/difficulty) to 100 (worst imaginable pain or complete inability).
- Subscale scores are calculated by averaging the responses within each category.
- The total AOS score is the average of the pain and disability subscale scores.
Measured: Preoperative, 3 months post op, 12 months post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2025
- Study start17 Nov 2025
- Primary completionAug 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Ankle ArthroplastyStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Responsible party
- Principal investigator, Sameh Labib, Emory University
- Investigators
- Sameh Labib, MD, FAOA, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07212114
- Sponsor's protocol ID
- STUDY00008684
- Other IDs
- 2025P010479
- Status last verified
- Feb 2026
- First submitted
- 2 Sep 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Active Controlled, Single-center Study to Evaluate the Efficacy of EXPAREL vs. Bupivacaine HCl Administered as Combined Sciatic (in the Popliteal Fossa) and Saphenous (in the Adductor Canal) Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Total Ankle Arthroplasty
- ClinicalTrials.gov ID
- NCT07212114
- Acronym / sponsor ID
- STUDY00008684
- Conditions
- Total Ankle Arthroplasty, Postsurgical Analgesia
- Keywords
- Pain management, Postsurgical Analgesia, Bupivacaine, EXPAREL
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Pacira Pharmaceuticals, Inc
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 8 Oct 2025 (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 goal of this clinical study is to learn about pain management strategies in subjects undergoing total ankle replacement. arthroplasty surgery The primary objective is to compare the magnitude of the analgesic effect following a single dose injection of EXPAREL vs. 0.25% bupivacaine (HCl).
Secondary objectives are to:
Compare the total opioid consumption (in oral morphine equivalents) from 0 to 96 hours following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl
- Compare the time to first opioid consumption following a single dose injection of EXPAREL vs. 0.25% bupivacaine HCl
- Assess the safety of EXPAREL vs. 0.25% bupivacaine HCl
- Evaluate subject satisfaction with pain management following a single-dose injection of EXPAREL vs. 0.25% bupivacaine hydrochloride (HCl)
- Compare clinical performance from Preoperative status to 3- and 12- months postoperatively
Detailed description
EXPAREL® is a long-acting local anesthetic specifically developed to provide extended postsurgical pain relief from a single-dose administration, thereby reducing or eliminating the need for indwelling catheters and minimizing reliance on supplemental opioid medications. It is currently indicated for single-dose infiltration to produce local analgesia in patients aged 6 years and older, as well as for regional analgesia via interscalene brachial plexus, sciatic (in the popliteal fossa), and adductor canal nerve blocks in adults. Pain following surgery is common, often peaking in the initial postoperative days, and if inadequately managed, it can delay healing, impair mobilization, prolong hospital stays, and increase the risk of complications and healthcare costs. Despite the prevalence of multimodal analgesic strategies-including the use of local anesthetics and systemic opioids-opioids remain a mainstay for moderate to severe postsurgical pain. However, their use is often limited by adverse effects such as respiratory depression, nausea, vomiting, pruritus, constipation, somnolence, and urinary retention. These complications not only reduce patient satisfaction and recovery but also increase medical intervention and resource use, making opioid-sparing alternatives clinically and economically attractive.
EXPAREL addresses this need by leveraging a proprietary multivesicular liposome (pMVL) drug delivery system that encapsulates bupivacaine at a concentration of 13.3 mg/mL within microscopic spherical vesicles. These vesicles-composed of naturally occurring or bioanalogous lipids-release bupivacaine gradually over time through lipid membrane reorganization and diffusion, thereby extending its duration of action well beyond the 6-8 hours typical of conventional bupivacaine formulations. The liposomal technology used in EXPAREL is based on the same pMVL platform found in the FDA-approved product DepoCyt®, though EXPAREL's lipid formulation has been modified for local anesthetic use. Since its initial FDA approval in 2011 for surgical site infiltration and the subsequent expansion of its indications in 2018 to include various nerve blocks, EXPAREL has been administered to approximately 14 million patients in the U.S., highlighting its growing adoption in clinical practice.
The rationale for the current study stems from the need to optimize postsurgical pain control in patients undergoing total ankle arthroplasty, a procedure associated with significant postoperative pain. This randomized, double-blind, active-controlled, single-center trial will evaluate the efficacy of EXPAREL when used in combination with bupivacaine HCl as part of a combined sciatic (popliteal fossa) and saphenous (adductor canal) nerve block regimen. Specifically, the intervention group will receive 20 mL EXPAREL (266 mg) admixed with 20 mL of 0.25% bupivacaine HCl (50 mg), while the control group will receive 40 mL of 0.25% bupivacaine HCl (100 mg), with each agent administered in equal volumes to the respective nerve sites. The objective is to determine whether the EXPAREL-based regimen provides more effective and longer-lasting analgesia compared to bupivacaine HCl alone, thereby enhancing recovery, reducing opioid consumption, and improving overall patient outcomes in a high-pain surgical population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Admix | Experimental | Drug: EXPAREL, Drug: 0.25% bupivacaine (HCl): 30 mlEXPAREL admixed with 0.25% bupivacaine HCl Total volume (50 mL) will be split such that 30 mL will be administered as the sciatic nerve block (in the popliteal fossa) and 20 mL will be administered as the saphenous nerve block (in the adductor canal) |
| Reference | Experimental | Drug: 0.25% bupivacaine (HCl): 50 mlBupivacaine HCl arm Total volume (50 mL) will be split such that 30 mL will be administered as the sciatic nerve block (in the popliteal fossa) and 20 mL will be administered as the saphenous nerve block (in the adductor canal) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Indicated to undergo unilateral total ankle arthroplasty
- American Society of Anesthesiologists (ASA) physical status 1, 2, or 3
- Able to provide informed consent, adhere to the study schedule, and complete all study assessments
- Body Mass Index (BMI) ≥18 and ≤40 kg/m2
Key exclusion criteria (14 listed)
- Allergy, hypersensitivity, intolerance, or contraindication to any of the study medications for which an alternative is not named in the protocol (e.g., amide-type local anesthetics, opioids, bupivacaine HCl, NSAIDs)
- Concurrent painful physical condition that may require analgesic treatment (such as long-term, consistent use of opioids) in the post-dosing period for pain, and which, in the Investigator's opinion, may confound the post-dosing assessments
- History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the Investigator, could interfere with study assessments or compliance
- Currently pregnant, nursing, or planning to become pregnant during the study
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 |
|---|---|---|
| EXPARELAlso: bupivacaine liposome injectable suspensionEXPAREL (bupivacaine liposome injectable suspension) is formulated as a sterile, non-pyrogenic, white to off-white, preservative-free homogenous suspension of bupivacaine encapsulated into multivesicular liposomes (pMVL drug delivery system). For this study, EXPAREL will be provided in 20 mL (266 mg) EXPAREL single-use, clear glass vials. | Drug | Admix |
| 0.25% bupivacaine (HCl): 50 mlThe reference product is 50 mL (100 mg) 0.25% bupivacaine HCl administered via a combined sciatic (in the popliteal fossa) and saphenous nerve block (in the adductor canal) | Drug | Reference |
| 0.25% bupivacaine (HCl): 30 mlEXPAREL admixed with 30 mL (75 mg) 0.25% bupivacaine HCl | Drug | Admix |
Primary outcome
Magnitude of the analgesic effect
Time frame: Perioperative (Upon arrival in the PACU (±5 min), Postoperative (At PACU discharge (±5 min)), Every 6 hours from the end of surgery until health care facility discharge up to 96h
To measure this, the Area under the curve (AUC) of the Numeric Rating Scale (NRS) for both groups will be compared. The subjects will be asked to rate their worst or average pain on a scale of 0 (no pain) - 10 (worst possible pain) on numerous time points, starting upon arrival in the Post-Anesthesia Care Unit (PACU)
9 secondary outcomes
Total opioid consumption
Time frame: Baseline (Hour 0), 96 hours post surgery
Time to first opioid consumption
Time frame: Baseline (Hour 0), 96 hours post surgery
Patient safety
Time frame: Baseline (Hour 0), Day 14 post op
Subject satisfaction
Time frame: Within 96 hours post op
Pain intensity: Numeric Rating Scale (NRS) Short term
Time frame: Every 6 hours from the end of surgery until health care facility discharge up to 96h
Pain intensity: Numeric Rating Scale (NRS) : post discharge
Time frame: Twice daily from the day of discharge upto Day 7 days post discharge
Pain intensity: Numeric Rating Scale (NRS): Long term
Time frame: Twice daily from the day 7 of discharge upto Day 14 post discharge
Clinical Performance: SF-12
Time frame: Preoperative, 3 months post op, 12 months post op
Clinical Performance: Ankle Osteoarthritis Score
Time frame: Preoperative, 3 months post op, 12 months post op
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 23 Feb 2026.
- Individual participant dataSharing planned: Yes. Individual de-identified participant data will be shared.
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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.
Sameh Labib, MD, FAOA principal investigator
Emory University
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 EXPAREL, 0.25% bupivacaine (HCl): 50 ml and 0.25% bupivacaine (HCl): 30 ml in people with Total Ankle Arthroplasty and Postsurgical Analgesia, run by Emory University 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 4 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 23 Feb 2026. 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?
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?
Contact Sameh Labib, MD, FAOA (404-778-4398, slabib@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnitude of the analgesic effect (time frame: Perioperative (Upon arrival in the PACU (±5 min), Postoperative (At PACU discharge (±5 min)), Every 6 hours from the end of surgery until health care facility discharge up to 96h). 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 23 Feb 2026.