Foot SurgeryPhase 4NCT06465992
Liposomal Bupivacaine With Dexamethasone for Foot Surgery
A Phase 4 study testing Exparel 266 MG Per 20 ML Injection, Bupivacaine Hcl 0.75% Inj and Dexamethasone in people with Foot Surgery and Ankle Surgery, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
This study aims to understand the ideal formulation to utilize in saphenous nerve and popliteal nerve blocks for foot and ankle procedures. It will examine the use of liposomal bupivacaine alone or liposomal bupivacaine with dexamethasone prior to foot and ankle procedures in peripheral nerve blocks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Foot Surgery, Ankle Surgery, Post Operative Pain
- What is being tested?
- Exparel 266 MG Per 20 ML Injection, Bupivacaine Hcl 0.75% Inj and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2024to 30 Jun 2025
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants with foot and ankle procedures at Jefferson Surgery Center, Navy Yard
- Participants with foot and ankle orthopedic procedures requiring a preoperative nerve block
- Age 18 and older
- English speaking
- Ability to complete surveys by phone or in person
- Ability to provide informed consent
Who cannot join
- Revision foot and ankle cases
- Allergies to study medications
- Non-English speakers
- Known alcohol or narcotic abuse history
- Existing contract with a pain specialist due to underlying preoperative pain syndrome
- Preoperative opioid use within the 3 months prior to surgery
- Participants who are pregnant, plan to become pregnant, or are breastfeeding.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Prior to Foot and Ankle Procedures: A Prospective Randomized Controlled Trial
This study aims to understand the ideal formulation to utilize in saphenous nerve and popliteal nerve blocks for foot and ankle procedures. It will examine the use of liposomal bupivacaine alone or liposomal bupivacaine with dexamethasone prior to foot and ankle procedures in peripheral nerve blocks. We will compare liposomal bupivacaine (Exparel) and liposomal bupivacaine (Exparel) combined with dexamethasone to determine if the addition of dexamethasone significantly decreases postoperative narcotic use and prolongs analgesic effects when administered in a popliteal and saphenous block prior to foot and ankle orthopedic procedures.
- Being tested
- Exparel 266 MG Per 20 ML Injection, Bupivacaine Hcl 0.75% Inj, Dexamethasone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exparel 266 MG Per 20 ML InjectionDrug
20 mL Liposomal bupivacaine (Exparel, 266 mg) will be administered in the popliteal and saphenous block
Bupivacaine Hcl 0.75% InjDrug
10 mL of 0.75% bupivacaine will be administered in popliteal and saphenous block
DexamethasoneDrug
1 mL of 10 mg Dexamethasone will be administered in the popliteal and saphenous block
| Study group | Role | What they receive |
|---|---|---|
| Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block | Active comparator | Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 10 mL of 0.75% bupivacaine Receives: Drug: Exparel 266 MG Per 20 ML Injection; Drug: Bupivacaine Hcl 0.75% Inj |
| Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block | Active comparator | Prior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 1 mL of 10 mg preservative free Dexamethasone + 10 cc's of 0.75% bupivacaine Receives: Drug: Exparel 266 MG Per 20 ML Injection; Drug: Bupivacaine Hcl 0.75% Inj; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of pain medication used after surgery
Collected as tablets taken since all participants will be prescribed oxycodone
Measured: 14 days
Pain level after surgery
Participants will be asked daily what their pain levels are using the Visual Analog (VAS) pain scale
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start17 Jun 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Foot SurgeryStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465992
- Sponsor's protocol ID
- DPED20242471
- Status last verified
- Jun 2024
- First submitted
- 14 Jun 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Prior to Foot and Ankle Procedures: A Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06465992
- Acronym / sponsor ID
- DPED20242471
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 17 Jun 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 20 Jun 2024 (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 aims to understand the ideal formulation to utilize in saphenous nerve and popliteal nerve blocks for foot and ankle procedures. It will examine the use of liposomal bupivacaine alone or liposomal bupivacaine with dexamethasone prior to foot and ankle procedures in peripheral nerve blocks. We will compare liposomal bupivacaine (Exparel) and liposomal bupivacaine (Exparel) combined with dexamethasone to determine if the addition of dexamethasone significantly decreases postoperative narcotic use and prolongs analgesic effects when administered in a popliteal and saphenous block prior to foot and ankle orthopedic procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block | Active comparator | Drug: Exparel 266 MG Per 20 ML Injection, Drug: Bupivacaine Hcl 0.75% InjPrior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 10 mL of 0.75% bupivacaine |
| Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block | Active comparator | Drug: Exparel 266 MG Per 20 ML Injection, Drug: Bupivacaine Hcl 0.75% Inj, Drug: DexamethasonePrior to participants surgical procedure, the anesthesiologist will administer a popliteal and saphenous nerve block consisting of 20 mL Liposomal bupivacaine (Exparel) + 1 mL of 10 mg preservative free Dexamethasone + 10 cc's of 0.75% bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants with foot and ankle procedures at Jefferson Surgery Center, Navy Yard
- Participants with foot and ankle orthopedic procedures requiring a preoperative nerve block
- Age 18 and older
- English speaking
- Ability to complete surveys by phone or in person
Key exclusion criteria (7 listed)
- Revision foot and ankle cases
- Allergies to study medications
- Non-English speakers
- Known alcohol or narcotic abuse history
- Existing contract with a pain specialist due to underlying preoperative pain syndrome
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 |
|---|---|---|
| Exparel 266 MG Per 20 ML Injection20 mL Liposomal bupivacaine (Exparel, 266 mg) will be administered in the popliteal and saphenous block | Drug | Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block, Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block |
| Bupivacaine Hcl 0.75% Inj10 mL of 0.75% bupivacaine will be administered in popliteal and saphenous block | Drug | Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block, Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block |
| Dexamethasone1 mL of 10 mg Dexamethasone will be administered in the popliteal and saphenous block | Drug | Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block |
Primary outcome
Amount of pain medication used after surgery
Time frame: 14 days
Collected as tablets taken since all participants will be prescribed oxycodone
Pain level after surgery
Time frame: 14 days
Participants will be asked daily what their pain levels are using the Visual Analog (VAS) pain scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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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.
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 Exparel 266 MG Per 20 ML Injection, Bupivacaine Hcl 0.75% Inj and Dexamethasone in people with Foot Surgery and Ankle Surgery, run by Rothman Institute Orthopaedics 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 6 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: status not confirmed, as of the sponsor's last update on 20 Jun 2024. 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?
Results are not available in the source record.
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?
Amount of pain medication used after surgery (time frame: 14 days). The study lists 2 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 20 Jun 2024.