Fracture Dislocation of Ankle JointPhase 4NCT07221019
Single Shot Exparel vs Catheters in Lower Extremity Trauma
A Phase 4 study testing Bupivacaine and Exparel + Bupivacaine in people with Fracture Dislocation of Ankle Joint and Fracture Leg, run by George Washington University at 1 site in United States.
Trial summary
This study will compare the use of single-shot Exparel, a long-acting local anesthestic, with the use of catheters that deliver a continuous flow of the short-acting local anesthetic ropivacaine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture Dislocation of Ankle Joint, Fracture Leg, Fracture Femur
- What is being tested?
- Bupivacaine and Exparel + Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2025to 11 Aug 2029
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Closed lower extremity orthopedic injury
- Opioid naive patients
- No other significant surgical injuries on admission as determined by study physician
Who cannot join
- Allergy to local anesthetics
- Multiple traumatic injuries
- Weight less than 60 kg
- Prior opioid use or risk of increased pain control needs as determined by PI
- Chronic opioid use
- Open fractures
- Plastic surgery needed for complete closure
- Patient has intraoperative cardiac arrest
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University Hospital
Washington D.C., District of Columbia, 20037
About this study
Official title: Single-Shot Exparel Versus Catheters for Lower Extremity Orthopedic Trauma Patients
This study will compare the use of single-shot Exparel, a long-acting local anesthestic, with the use of catheters that deliver a continuous flow of the short-acting local anesthetic ropivacaine. The comparison will be done in patients who receive preoperative adductor and sciatic nerve blocks prior to orthopedic surgery for traumatic lower extremity injury. The patients' pain will then be monitored for up to 72 hours after injection, measuring every 12 hours after injection until the 72-hour mark. Opioid consumption (measured in morphine milligram equivalents) will also be tracked over this time period.
Read the detailed description
The use of Exparel has been widely criticized over the past few years with regard to its efficacy compared to perineural catheters and whether or not it truly lasts 72 hours, as is often advertised. However, it is still used in many centers for the proposed increased duration of action and ease of use compared to indwelling catheters, which require a greater degree of monitoring and follow-up for removal. Various studies conducted have looked at the efficacy of Exparel and have found no superiority over nerve blocks with other local anesthetic agents. However, nerve blocks with catheters have never been directly compared to exparel injections for pain control. As such, the goal of this study is to elucidate whether there truly is a difference between the two. In this study, the study team will compare preoperative adductor and sciatic nerve blocks with exparel versus catheters in orthopedic surgery patients who present with a traumatic lower extremity injury. Exparel has been documented to increase the duration of a nerve block by up to 72 hours. Studies comparing exparel single shot versus bupivacaine single shot have favored for the latter, which pharmacodynamically makes sense. A liposomal compound which slowly denatures to present an active component would seemingly be unlikely to match up against the higher concentration of said active component flood the desired site of action. In our study, the study team plans to measure the duration of the block with the addition of exparel in comparison to the duration of the block with a catheter which is connected to a pump continuously infusing a set rate of local anesthetics. Our primary research question is whether there is a statistically significant difference in pain control for 72 hours post-op in lower extremity orthopedic trauma when using Exparel versus a short-acting local anesthetic supplied via continuous infusion, in this case ropivacaine.
- Conditions
- Fracture Dislocation of Ankle Joint, Fracture Leg, Fracture Femur, Fracture Lower Leg, Fracture
- Being tested
- Bupivacaine, Exparel + Bupivacaine
- Medical subject headings
- Femoral Fractures, Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Patients will receive the ERAS standard of care which includes gabapentin, Tylenol, and Toradol or Celebrex preoperatively as well as 20 cc of 0.25% bupivacaine with 10 cc of Exparel injected in the adductor space followed by 30 cc of 0.25% bupivacaine with 10 cc of Exparel in the sciatic nerve block. Injections will be completed by an anesthesia provider using astandard aseptic technique with ultrasound guidance. A 22 gauge 5-10cm needle is inserted with direct visualization under ultrasound and 2-5 cc aliquots are injected with aspiration repeated to ensure no vascular injury or injection until a total of 30 cc is injected into the adductor space and 40 cc is injected into the area surrounding the sciatic nerve. Exparel in this situation is being used off-label given that it is not FDA-approved for lower extremity nerve blocks. However, Exparel is commonly used in other nerve blocks and is FDA-approved for blocks such as the interscalene brachial plexus block.
Exparel + BupivacaineDrug
Patients will receive the ERAS standard of care which includes gabapentin, Tylenol, and Toradol or Celebrex preoperatively as well as 20 cc of 0.25% bupivacaine injected in the adductor space followed by 30 cc of 0.25% bupivacaine in the sciatic nerve block. Injections will be completed by an anesthesia provider in the same manner as above. Catheters will be left in both spaces with post-operative pumps running 0.2% ropivacaine at 8 cc/hr.
| Study group | Role | What they receive |
|---|---|---|
| Exparel + Bupivacaine | Experimental | Not described Receives: Drug: Exparel + Bupivacaine |
| Bupivacaine | Active comparator | Not described Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Score
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Measured: 12 hours
Postoperative Pain Score
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Measured: 24 hours
Postoperative Pain Score
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Measured: 36 hours
Postoperative Pain Score
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Measured: 48 hours
Postoperative Pain Score
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Measured: 60 hours
Postoperative Pain Score
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Measured: 72 hours
Secondary outcomes (3)
Morphine equivalents
Morphine equivalents at 24 hours postoperatively
Measured: Day 1
Morphine equivalents
Morphine equivalents at 24-48 hours postoperatively
Measured: Day 2
Morphine equivalents
Morphine equivalents at 48-72 hours postoperatively
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2025
- Study start12 Sep 2025
- Primary completion11 Aug 2028 (estimated)
- Study completion11 Aug 2029 (estimated)
Why it stopped: The PI is no longer with the institution, and there is no interest to continue this study by other faculty members.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fracture Dislocation of Ankle JointStudies of the same condition, open and under way.
- More trials run by George Washington 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221019
- Sponsor's protocol ID
- NCR256547
- Status last verified
- Sep 2026
- First submitted
- 23 Oct 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Shot Exparel Versus Catheters for Lower Extremity Orthopedic Trauma Patients
- ClinicalTrials.gov ID
- NCT07221019
- Acronym / sponsor ID
- NCR256547
- Conditions
- Fracture Dislocation of Ankle Joint, Fracture Leg, Fracture Femur, Fracture Lower Leg, Fracture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI is no longer with the institution, and there is no interest to continue this study by other faculty members.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 11 Aug 2028 (estimated)
- Study completion
- 11 Aug 2029 (estimated)
- First posted
- 27 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.
This study will compare the use of single-shot Exparel, a long-acting local anesthestic, with the use of catheters that deliver a continuous flow of the short-acting local anesthetic ropivacaine. The comparison will be done in patients who receive preoperative adductor and sciatic nerve blocks prior to orthopedic surgery for traumatic lower extremity injury. The patients' pain will then be monitored for up to 72 hours after injection, measuring every 12 hours after injection until the 72-hour mark. Opioid consumption (measured in morphine milligram equivalents) will also be tracked over this time period.
Detailed description
The use of Exparel has been widely criticized over the past few years with regard to its efficacy compared to perineural catheters and whether or not it truly lasts 72 hours, as is often advertised. However, it is still used in many centers for the proposed increased duration of action and ease of use compared to indwelling catheters, which require a greater degree of monitoring and follow-up for removal. Various studies conducted have looked at the efficacy of Exparel and have found no superiority over nerve blocks with other local anesthetic agents. However, nerve blocks with catheters have never been directly compared to exparel injections for pain control. As such, the goal of this study is to elucidate whether there truly is a difference between the two. In this study, the study team will compare preoperative adductor and sciatic nerve blocks with exparel versus catheters in orthopedic surgery patients who present with a traumatic lower extremity injury. Exparel has been documented to increase the duration of a nerve block by up to 72 hours. Studies comparing exparel single shot versus bupivacaine single shot have favored for the latter, which pharmacodynamically makes sense. A liposomal compound which slowly denatures to present an active component would seemingly be unlikely to match up against the higher concentration of said active component flood the desired site of action. In our study, the study team plans to measure the duration of the block with the addition of exparel in comparison to the duration of the block with a catheter which is connected to a pump continuously infusing a set rate of local anesthetics. Our primary research question is whether there is a statistically significant difference in pain control for 72 hours post-op in lower extremity orthopedic trauma when using Exparel versus a short-acting local anesthetic supplied via continuous infusion, in this case ropivacaine.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exparel + Bupivacaine | Experimental | Drug: Exparel + Bupivacaine |
| Bupivacaine | Active comparator | Drug: Bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Closed lower extremity orthopedic injury
- Opioid naive patients
- No other significant surgical injuries on admission as determined by study physician
Key exclusion criteria (8 listed)
- Allergy to local anesthetics
- Multiple traumatic injuries
- Weight less than 60 kg
- Prior opioid use or risk of increased pain control needs as determined by PI
- Chronic opioid use
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 |
|---|---|---|
| BupivacainePatients will receive the ERAS standard of care which includes gabapentin, Tylenol, and Toradol or Celebrex preoperatively as well as 20 cc of 0.25% bupivacaine with 10 cc of Exparel injected in the adductor space followed by 30 cc of 0.25% bupivacaine with 10 cc of Exparel in the sciatic nerve block. Injections will be completed by an anesthesia provider using astandard aseptic technique with ultrasound guidance. A 22 gauge 5-10cm needle is inserted with direct visualization under ultrasound and 2-5 cc aliquots are injected with aspiration repeated to ensure no vascular injury or injection until a total of 30 cc is injected into the adductor space and 40 cc is injected into the area surrounding the sciatic nerve. Exparel in this situation is being used off-label given that it is not FDA-approved for lower extremity nerve blocks. However, Exparel is commonly used in other nerve blocks and is FDA-approved for blocks such as the interscalene brachial plexus block. | Drug | Bupivacaine |
| Exparel + BupivacainePatients will receive the ERAS standard of care which includes gabapentin, Tylenol, and Toradol or Celebrex preoperatively as well as 20 cc of 0.25% bupivacaine injected in the adductor space followed by 30 cc of 0.25% bupivacaine in the sciatic nerve block. Injections will be completed by an anesthesia provider in the same manner as above. Catheters will be left in both spaces with post-operative pumps running 0.2% ropivacaine at 8 cc/hr. | Drug | Exparel + Bupivacaine |
Primary outcome
Postoperative Pain Score
Time frame: 12 hours
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Postoperative Pain Score
Time frame: 24 hours
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Postoperative Pain Score
Time frame: 36 hours
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Postoperative Pain Score
Time frame: 48 hours
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Postoperative Pain Score
Time frame: 60 hours
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
Postoperative Pain Score
Time frame: 72 hours
Visual Analog Scale on a scale of 0-10 (0 is no pain and 10 is the worst pain)
3 secondary outcomes
Morphine equivalents
Time frame: Day 1
Morphine equivalents
Time frame: Day 2
Morphine equivalents
Time frame: Day 3
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Bupivacaine and Exparel + Bupivacaine in people with Fracture Dislocation of Ankle Joint and Fracture Leg, run by George Washington 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 3 inclusion and 8 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: withdrawn, as of the sponsor's last update on 24 Sep 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Postoperative Pain Score (time frame: 12 hours). 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 24 Sep 2026; AzTrials last refreshed its copy on 6 Nov 2026.