Pain, PostoperativePhase 4NCT05494645
Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery
A Phase 4 study testing Exparel and Peripheral Nerve Block in people with Pain, Postoperative and Pain, Acute Postoperative, run by St. Luke's Hospital, Pennsylvania at 1 site in United States.
Trial summary
Liposomal Bupivacaine (Exparel) has been recently studied as the active agent utilized in various nerve block. Due to its liposomal form allowing for extended delivery, Exparel has been used in various peri-operative nerve blocks among multiple orthopaedic specialties in hopes of achieving improved pain control and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Pain, Acute Postoperative, Ankle Fractures
- What is being tested?
- Exparel and Peripheral Nerve Block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 31 Jan 2023
- 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
- Adult patients undergoing elective orthopaedic foot and ankle surgery at a single institution
- English speaking
- Able to provide consent to surgery and study participation
Who cannot join
- Non-elective or emergent foot and ankle surgery
- Non-english speaking
- Does not possess medical decision making capacity
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's University Health Network
Bethlehem, Pennsylvania, 18015
About this study
Official title: Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery: A Randomized Controlled Trial
Liposomal Bupivacaine (Exparel) has been recently studied as the active agent utilized in various nerve block. Due to its liposomal form allowing for extended delivery, Exparel has been used in various peri-operative nerve blocks among multiple orthopaedic specialties in hopes of achieving improved pain control and decreased opioid use. This study compares the efficacy and effect on opioid use of peripheral nerve blocks and local infiltration with and without Exparel in patients undergoing foot and ankle surgery.
Read the detailed description
three study groups: A - surgeon infiltrates with exparel on site of surgery; B - anesthesia provides a regional nerve block (popliteal/adductor blocks) with plain local anesthetic (bupivacaine); C - anesthesia provides a regional nerve block (popliteal/adductor) with Exparel/bupivacaine mix. Follow up occurs on postop day 4 via phone call to patient. Measured outcomes include opioid consumption in post anesthesia care unit phase (oral morphine equivalents), block duration, number of opioid pills used by postop day 4, oral morphine equivalent consumption by postop day 4.
- Conditions
- Pain, Postoperative, Pain, Acute Postoperative, Ankle Fractures, Ankle Injuries and Disorders
- Being tested
- Exparel, Peripheral Nerve Block
- Keywords
- liposomal bupivacaine, ankle surgery, postoperative pain, regional nerve block
- Medical subject headings
- Pain, Postoperative, Ankle Fractures, Ankle Injuries, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
Also called Liposomal bupivicaine
Liposomal bupivicaine
Peripheral Nerve BlockDrug
Also called marcaine, bupivicaine
Peripheral nerve block without Exparel
| Study group | Role | What they receive |
|---|---|---|
| Peripheral Nerve Block Without Exparel | Active comparator | Lower extremity peripheral nerve block without Exparel: 0.25-0.5% bupivacaine Receives: Drug: Peripheral Nerve Block |
| Peripheral Nerve Block with Exparel | Experimental | Liposomal bupivicaine administered for peripheral nerve block: mixed with 0.25-0.5% bupivacaine Receives: Drug: Exparel |
| Local Infiltration of Exparel | Experimental | Liposomal bupivicaine administered by surgeon intra-operatively in field block, mix with 0.25% bupivacaine Receives: Drug: Exparel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of block
Measured: 1 year
Secondary outcomes (3)
number of opioid pills used by postoperative day # 4
Measured: 1 year
PROMIS Scores
Measured: 1 year
oral morphine equivalent use by postoperative day 4
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Mar 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies 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
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's Hospital, Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Ng-Pellegrino, Principal investigator, St. Luke's Hospital and Health Network, Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494645
- Sponsor's protocol ID
- SLRI-2022-24
- Status last verified
- Jan 2025
- First submitted
- 8 Aug 2022
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McKeeman J, Smith B, Malige A, Bates R, Pellegrino AN, Lachman J. Efficacy of Liposomal Bupivacaine in Ultrasound-Guided Peripheral Nerve Blocks for Postoperative Pain Management in Foot and Ankle Surgery. Foot Ankle Int. 2025 Oct;46(10):1147-1155. doi: 10.1177/10711007251359634. Epub 2025 Sep 8.
PubMed 40916868
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exparel Use in Peripheral Nerve Blocks and Local Infiltration for Foot and Ankle Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05494645
- Acronym / sponsor ID
- SLRI-2022-24
- Conditions
- Pain, Postoperative, Pain, Acute Postoperative, Ankle Fractures, Ankle Injuries and Disorders
- Keywords
- liposomal bupivacaine, ankle surgery, postoperative pain, regional nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- St. Luke's Hospital, PennsylvaniaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 10 Aug 2022 (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.
Liposomal Bupivacaine (Exparel) has been recently studied as the active agent utilized in various nerve block. Due to its liposomal form allowing for extended delivery, Exparel has been used in various peri-operative nerve blocks among multiple orthopaedic specialties in hopes of achieving improved pain control and decreased opioid use. This study compares the efficacy and effect on opioid use of peripheral nerve blocks and local infiltration with and without Exparel in patients undergoing foot and ankle surgery.
Detailed description
three study groups: A - surgeon infiltrates with exparel on site of surgery; B - anesthesia provides a regional nerve block (popliteal/adductor blocks) with plain local anesthetic (bupivacaine); C - anesthesia provides a regional nerve block (popliteal/adductor) with Exparel/bupivacaine mix. Follow up occurs on postop day 4 via phone call to patient. Measured outcomes include opioid consumption in post anesthesia care unit phase (oral morphine equivalents), block duration, number of opioid pills used by postop day 4, oral morphine equivalent consumption by postop day 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Peripheral Nerve Block Without Exparel | Active comparator | Drug: Peripheral Nerve BlockLower extremity peripheral nerve block without Exparel: 0.25-0.5% bupivacaine |
| Peripheral Nerve Block with Exparel | Experimental | Drug: ExparelLiposomal bupivicaine administered for peripheral nerve block: mixed with 0.25-0.5% bupivacaine |
| Local Infiltration of Exparel | Experimental | Drug: ExparelLiposomal bupivicaine administered by surgeon intra-operatively in field block, mix with 0.25% 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)
- Adult patients undergoing elective orthopaedic foot and ankle surgery at a single institution
- English speaking
- Able to provide consent to surgery and study participation
Key exclusion criteria (3 listed)
- Non-elective or emergent foot and ankle surgery
- Non-english speaking
- Does not possess medical decision making capacity
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: Liposomal bupivicaineLiposomal bupivicaine | Drug | Local Infiltration of Exparel, Peripheral Nerve Block with Exparel |
| Peripheral Nerve BlockAlso: marcaine, bupivicainePeripheral nerve block without Exparel | Drug | Peripheral Nerve Block Without Exparel |
Primary outcome
Duration of block
Time frame: 1 year
3 secondary outcomes
number of opioid pills used by postoperative day # 4
Time frame: 1 year
PROMIS Scores
Time frame: 1 year
oral morphine equivalent use by postoperative day 4
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Derived from this study: PubMed 40916868McKeeman J, Smith B, Malige A, Bates R, Pellegrino AN, Lachman J. Efficacy of Liposomal Bupivacaine in Ultrasound-Guided Peripheral Nerve Blocks for Postoperative Pain Management in Foot and Ankle Surgery. Foot Ankle Int. 2025 Oct;46(10):1147-1155. doi: 10.1177/10711007251359634. Epub 2025 Sep 8.
- 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.
Anna Ng-Pellegrino principal investigator
St. Luke's Hospital and Health Network, Pennsylvania
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 and Peripheral Nerve Block in people with Pain, Postoperative and Pain, Acute Postoperative, run by St. Luke's Hospital, Pennsylvania 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 3 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 28 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 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Duration of block (time frame: 1 year). 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 NCT05494645, which also lists 1 linked publication.
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 28 Apr 2026; AzTrials last refreshed its copy on 1 Nov 2026.