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

126 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this 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.

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.

Is Liposomal Bupivacaine + Dexamethasone safe for use in foot surgery?

Dexamethasone, a type of steroid, is generally considered safe for reducing pain and inflammation after foot surgery, though it may delay healing and increase infection risk. Liposomal bupivacaine has been used safely in foot surgeries, with no significant adverse events reported. However, more research is needed to fully understand the safety of combining these treatments. ^{1 2 3 4 5}

How does the drug Liposomal Bupivacaine + Dexamethasone differ from other treatments for foot surgery?

Liposomal Bupivacaine + Dexamethasone is unique because it combines a long-lasting local anesthetic (bupivacaine) with an anti-inflammatory steroid (dexamethasone) to potentially extend pain relief after foot surgery, reducing the need for opioids. This combination aims to provide prolonged pain control and reduce inflammation, which is different from standard treatments that may not offer extended pain relief or include anti-inflammatory benefits. ^{1 3 6 7 8}

What data supports the effectiveness of the drug Dexamethasone for foot surgery?

Research shows that dexamethasone can reduce pain after foot surgery, as patients reported less pain in the foot treated with the steroid compared to the untreated foot in a study on bunion surgery. ^{1 3 6 9 10}

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

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

Allergies to study medications

Non-English speakers

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

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Dexamethasone Addition to Popliteal Nerve Blocks: Effects on Duration of Analgesia and Incidence of Postoperative Nerve Complication. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine in forefoot surgery. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A comparison of the efficacy of injectable dexamethasone sodium phosphate versus placebo in postoperative podiatric analgesia. [2019]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Analgesia after Epidural Dexamethasone is Further Enhanced by IV Dipyrone, but Not IV Parecoxibe Following Minor Orthopedic Surgery. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. Japan pubmed.ncbi.nlm.nih.gov

Efficacy of epidural dexamethasone versus fentanyl on postoperative analgesia. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine in hallux valgus surgery: a multimodal pain management adjunct. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Use of postoperative steroids to reduce pain and inflammation. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Prolonged duration local anesthesia with lipid-protein-sugar particles containing bupivacaine and dexamethasone. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Dexamethasone Does not Compensate for Local Anesthetic Cytotoxic Effects on Tenocytes: Morphine or Morphine Plus Dexamethasone May Be a Safe Alternative. [2022]