Liposomal Bupivacaine + Dexamethasone for Foot Surgery

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rothman Institute Orthopaedics

Must not be taking: Opioids

Disqualifiers: Revision cases, Allergies, Abuse history, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two different pain management options for individuals undergoing foot and ankle surgery. Researchers aim to determine whether adding dexamethasone (a corticosteroid) to liposomal bupivacaine (a long-lasting pain reliever) can reduce the need for painkillers after surgery and extend pain relief. The study targets those scheduled for foot or ankle surgery who require a nerve block for pain management before the procedure. This trial may suit individuals with planned foot or ankle surgery needing pain management. As a Phase 4 trial, the treatment has already received FDA approval and proven effective, with the goal of understanding its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used opioids in the 3 months before surgery.

What is the safety track record for these treatments?

Research has shown that liposomal bupivacaine, also known as Exparel, is generally safe and effective for pain relief during surgeries. Studies indicate it has a good safety record when used in nerve blocks, typically not causing serious side effects.

When combined with dexamethasone, the safety profile remains positive. Dexamethasone, a steroid often used to reduce pain and swelling, is generally safe but may slow healing in some cases.

This trial is in Phase 4, indicating that earlier studies have tested the safety of both treatments, and they have received FDA approval. This suggests they are considered safe for use. However, like any medication, they can have side effects, so discussing these with the trial team or a doctor is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using a combination of liposomal bupivacaine and dexamethasone for foot and ankle surgery because it offers a potentially more effective pain management strategy compared to traditional nerve blocks. Unlike standard treatments that typically rely on plain bupivacaine, this approach includes liposomal bupivacaine, which is designed to release the medication slowly over time, potentially extending pain relief. Additionally, the inclusion of dexamethasone, a potent anti-inflammatory steroid, may enhance the pain-relieving effects and reduce swelling. By combining these elements, the treatment aims to provide longer-lasting and more comprehensive pain control, which could lead to improved recovery experiences for patients.

What evidence suggests that this trial's treatments could be effective for foot and ankle surgery?

Research has shown that using liposomal bupivacaine in nerve blocks can reduce the need for painkillers after surgery. Patients have reported feeling less pain for several days following their procedures. In this trial, participants in Study Group 1 will receive a nerve block with liposomal bupivacaine alone. Meanwhile, Study Group 2 will receive a nerve block with the addition of dexamethasone, a type of steroid, to liposomal bupivacaine. Studies indicate that this combination can further decrease pain after surgery and manage pain effectively without increasing wound problems. Overall, evidence suggests these treatments effectively control pain after foot and ankle surgeries. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing foot or ankle surgery who are interested in better pain management. The study is looking at patients receiving nerve blocks before their procedures to see if adding a medication, dexamethasone, can improve pain control.

Inclusion Criteria

I had a foot or ankle surgery at Jefferson Surgery Center, Navy Yard.

Ability to provide informed consent

I can complete surveys over the phone or in person.

Exclusion Criteria

Allergies to study medications

Non-English speakers

I am undergoing or have undergone a revision surgery on my foot or ankle.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a popliteal and saphenous nerve block with either liposomal bupivacaine alone or combined with dexamethasone prior to foot and ankle surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pain levels and medication use post-surgery

2 weeks

Daily monitoring (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview The study tests two approaches: one using liposomal bupivacaine (Exparel) alone and another combining Exparel with dexamethasone for nerve blocks. It aims to determine if the combination offers superior postoperative pain relief and reduces the need for narcotics after foot and ankle surgeries.

How Is the Trial Designed?

Group I: Study Group 1: Foot/Ankle Surgery with Exparel Nerve Block Active Control 2 Interventions

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

Group II: Study Group 2: Foot/Ankle Surgery with Exparel + Dexamethasone Nerve Block Active Control 3 Interventions

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

Who Is Running the Clinical Trial?

Rothman Institute Orthopaedics

Lead Sponsor

Trials

127

Recruited

22,600+

Published Research Related to This Trial

Adding dexamethasone to epidural bupivacaine provides similar analgesic effects as adding fentanyl, significantly prolonging the time to first analgesic requirement and reducing postoperative pain medication consumption in patients after lower abdominal surgeries.

Dexamethasone also offers additional benefits, such as lower postoperative nausea compared to both bupivacaine alone and bupivacaine with fentanyl, highlighting its potential as an effective and safer option for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of epidural dexamethasone versus fentanyl on postoperative analgesia. Khafagy, HF., Refaat, AI., El-Sabae, HH., et al.[2022]

In a study of 40 patients undergoing forefoot surgery, those who received liposomal bupivacaine consumed significantly fewer narcotic pills on the first two postoperative days compared to the control group, indicating its effectiveness in reducing opioid consumption.

Patients receiving liposomal bupivacaine reported lower pain scores during the first four days after surgery, and there were no increased wound complications, suggesting it is a safe and effective addition to postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine in forefoot surgery. Robbins, J., Green, CL., Parekh, SG.[2022]

Epidural administration of dexamethasone provided effective pain relief after minor orthopedic surgery, lasting about 7 hours, and reduced the need for additional painkillers compared to the control group.

Combining epidural dexamethasone with IV dipyrone significantly extended pain relief to 17 hours and decreased overall painkiller consumption, while adding IV parecoxibe did not enhance the analgesic effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesia after Epidural Dexamethasone is Further Enhanced by IV Dipyrone, but Not IV Parecoxibe Following Minor Orthopedic Surgery. Lauretti, GR., Righeti, CC., Kitayama, AT.[2021]

In a double-blind study involving 51 patients undergoing bunion surgery, dexamethasone sodium phosphate significantly reduced postoperative pain compared to normal saline, as reported by patients at 24 hours and from 4 to 7 days after surgery.

No complications were linked to the use of dexamethasone, supporting its safety and efficacy as a postoperative analgesic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative analgesic effects of dexamethasone sodium phosphate in bunion surgery. Curda, GA.[2016]

In a pilot study involving 49 patients undergoing foot and ankle surgery, the addition of 8 mg dexamethasone to nerve blocks did not significantly improve the duration of pain relief or reduce the incidence of postoperative neuropathic complications compared to nerve blocks alone.

The study suggests that while dexamethasone is commonly used to enhance pain management, its effectiveness in this context remains uncertain, indicating the need for further research with a larger sample size to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone Addition to Popliteal Nerve Blocks: Effects on Duration of Analgesia and Incidence of Postoperative Nerve Complication. Noori, N., Anand, K., Pfeffer, G., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02072135

Study Details | NCT02072135 | Exparel and Ankle Surgery EXPAREL® has been shown to provide successful prolonged analgesia after wound infiltration during several surgical procedures.In addition to the long lasting ...

2. journals.sagepub.com journals.sagepub.com/doi/abs/10.1177/10711007251359634

Efficacy of Liposomal Bupivacaine in Ultrasound-Guided ... Conclusion: US-guided peripheral nerve blocks using liposomal bupivacaine were associated with reduced postoperative opioid consumption and ...

3. jbjs.org jbjs.org/reader.php?rsuite_id=1465b124-eb1a-41fc-a2ff-044d0c6a95cf

Practical Considerations for Liposomal Bupivacaine Use in ... A recent systematic review of 4 RCTs showed mixed to positive results, with some studies showing better pain management and lower opioid ...

4. dovepress.com dovepress.com/clinical-effectiveness-of-perineural-liposomal-bupivacaine-is-not-supe-peer-reviewed-fulltext-article-JPR

Clinical Effectiveness of Perineural Liposomal Bupivacaine ... The primary outcomes were NRS scores and opioid consumption at postoperative 24– 72 hours. A minimum difference of 2.0 points on NRS scores or ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40916868/

Efficacy of Liposomal Bupivacaine in Ultrasound-Guided ... Conclusion: US-guided peripheral nerve blocks using liposomal bupivacaine were associated with reduced postoperative opioid consumption and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12277084/

Clinical Effectiveness of Perineural Liposomal Bupivacaine is ... Clinical Effectiveness of Perineural Liposomal Bupivacaine is Not Superior to Bupivacaine Hydrochloride for the Prevention of Postoperative Pain ...

7. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-023-03583-1

The use of liposomal bupivacaine in fracture surgery: a review This systematic review of the available data identified a total of eight studies evaluating the use of liposomal bupivacaine in patients with fractures.