Pain Control Methods for Ankle Surgery

(PvP Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Campbell Clinic

Must not be taking: Injectable anesthetics, Narcotics

Disqualifiers: Chronic pain, Peripheral neuropathy, 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

Compensation: Varies

Number of Visits: 3

Duration: Immediate perioperative period

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those with long-term narcotic use. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the drug Bupivacaine, Exparel, Exparel, bupivacaine liposome injectable suspension for pain control in ankle surgery?

Research shows that liposomal bupivacaine (Exparel) is effective in reducing postoperative pain and the need for opioids in various surgeries, including orthopedic trauma, by providing long-lasting pain relief. This suggests it could be beneficial for managing pain after ankle surgery as well. ^{1 2 3 4 5}

Is liposome bupivacaine (Exparel) safe for use in humans?

Liposome bupivacaine (Exparel) has been shown to be generally safe for use in humans, with a safety profile similar to regular bupivacaine. It is used to manage pain after surgery and has been tested in various clinical trials, showing effective pain control with dose-related side effects. ^{1 3 4 6 7}

How does the drug used in the trial for ankle surgery pain control differ from other treatments?

The drug used in the trial, liposome bupivacaine (Exparel), is unique because it is an extended-release local anesthetic that can be directly injected into the surgical site, providing pain relief for up to 72 hours. This differs from other treatments that may require more frequent dosing or have a shorter duration of pain control. ^{1 2 3 4 8}

What is the purpose of this trial?

This study aims to determine the effectiveness and safety of two standard of care perioperative procedures for controlling pain following ankle and hindfoot osteotomy or fusion or ankle fracture repair.

Research Team

Garnett A Murphy, MD

Principal Investigator

Campbell Clinic

Eligibility Criteria

This trial is for adults aged 18-80 who need foot or ankle surgery and can follow the study plan, including all visits. They must be healthy enough for surgery (ASA I-III), speak English, and have their operation at Campbell Surgery Center. People with diabetes must have an Hbg A1C of 7 mg/dl or less. Those with chronic pain conditions, peripheral neuropathy, long-term narcotic use, or allergies to certain anesthetics cannot join.

Inclusion Criteria

My surgery is scheduled at Campbell Surgery Center in Germantown, TN.

I have had surgery to correct bone structure in my ankle or to repair a broken ankle.

ASA I-III with medical clearances as needed

Exclusion Criteria

You have been taking strong painkillers for a long time before the surgery.

I have been diagnosed with chronic pain syndrome.

Hbg A1C is > 7 mg/dl in diabetic patients only

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a periarticular injection or a popliteal block for pain control during ankle or hindfoot surgery

Immediate perioperative period

1 visit (in-person)

Follow-up

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

12 weeks

Multiple visits (in-person and virtual) at weeks 2, 6, and 12

Treatment Details

Interventions

• Bupivicaine
• Exparel

Trial Overview The study compares two pain control methods after foot or ankle bone surgery: a periarticular injection using Exparel versus a popliteal block with Bupivicaine. The goal is to see which one is more effective and safer for managing post-surgery pain.

Participant Groups

Group I: Periarticular Injection Active Control 1 Intervention

Subjects undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair will recieve a periarticular injection by the surgeon using 10 milliliters of Exparel mixed with 10 milliliters of bupivicaine 0.5 percent at the end of the procedure.

Group II: Popliteal Block Active Control 1 Intervention

Subjects undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair will recieve a popliteal block by the anesthesiologist using 30 milliliters of bupivicaine 0.5 percent in the pre-operative area, prior to surgery, using an ultrasound machine for guidance.

Who Is Running the Clinical Trial?

Campbell Clinic

Lead Sponsor

Trials

15

Recruited

2,100+

Findings from Research

In a retrospective analysis of 575 subjects across 6 clinical trials, liposome bupivacaine showed a similar safety profile to both bupivacaine HCl and normal saline, with 76% of liposome bupivacaine recipients experiencing adverse events (AEs).

The most common AEs for liposome bupivacaine included nausea and hypesthesia, and serious AEs occurred in 8% of subjects, indicating that the side effects are likely related to the surgical procedure rather than the medication itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Ilfeld, BM., Viscusi, ER., Hadzic, A., et al.[2022]

In a study involving 59 patients undergoing total knee arthroplasty, liposomal bupivacaine did not show a significant clinical advantage over standard bupivacaine in terms of postoperative recovery, as measured by the number of physical therapy sessions needed for discharge.

The use of liposomal bupivacaine was associated with higher medication charges, raising concerns about its cost-effectiveness compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. Hyland, SJ., Deliberato, DG., Fada, RA., et al.[2019]

In a pilot study involving 25 pigs, subarachnoid administration of liposomal bupivacaine resulted in a longer duration of pain relief compared to standard bupivacaine hydrochloride, with effects lasting up to 32 hours for higher doses.

No signs of neurotoxicity were observed in any treatment group, suggesting that liposomal bupivacaine may be a safe option for extended analgesia in the neuraxial space, warranting further studies for potential human use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. Zel, J., Hadzic, A., Cvetko, E., et al.[2019]

EXPAREL® (bupivacaine liposome injectable suspension) is an effective extended-release local anesthetic that can significantly improve postoperative pain management in orthopedic trauma surgery, as demonstrated in two case studies.

Both patients treated with EXPAREL® experienced good control of postsurgical pain, highlighting its safety and efficacy as part of a multimodal analgesia approach in reducing the risk of chronic pain after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local infiltration of liposome bupivacaine in orthopedic trauma patients: case-based reviews. Hutchinson, HL.[2022]

In a study involving 100 patients with pulpal necrosis, liposomal bupivacaine did not show a statistically significant improvement in postoperative pain relief compared to standard bupivacaine, with success rates of 29% and 22% respectively.

While liposomal bupivacaine had some effects on soft tissue numbness and non-narcotic medication use, these effects were not clinically significant, indicating that it may not provide additional benefits over traditional bupivacaine for postoperative pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Liposomal Bupivacaine (Exparel) Significantly Reduce Postoperative Pain/Numbness in Symptomatic Teeth with a Diagnosis of Necrosis? A Prospective, Randomized, Double-blind Trial. Glenn, B., Drum, M., Reader, A., et al.[2017]

In a study involving 98 mice, liposomal bupivacaine (Exparel®) provided a longer duration of pain relief compared to standard bupivacaine, with motor block lasting up to 180 minutes and thermoalgesic block lasting up to 420 minutes.

The addition of dexamethasone, either perineurally or systemically, significantly reduced neural inflammation caused by bupivacaine, and perineural dexamethasone also helped reduce inflammation from Exparel®, suggesting a protective effect against nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. Ferré, F., Krin, A., Sanchez, M., et al.[2020]

DepoFoam bupivacaine, an extended-release formulation of the local anesthetic bupivacaine, provides effective pain relief for 3-4 days after a single administration at the surgical site, reducing the need for opioid pain relief.

The safety profile of DepoFoam bupivacaine is comparable to traditional bupivacaine HCl, with adverse events being dose-related, indicating it is a safe option for managing postsurgical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of DepoFoam(®) bupivacaine for the treatment of postsurgical pain. Bergese, SD., Onel, E., Portillo, J.[2014]

EXPAREL® (bupivacaine liposome injectable suspension) provides effective pain relief for up to 72 hours after foot and ankle surgeries, making it a valuable option for outpatient procedures.

In two case studies involving complex surgeries, both patients experienced excellent control of postsurgical pain, highlighting the efficacy of EXPAREL® in managing pain without the risks associated with more extensive nerve blocks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local infiltration of liposome bupivacaine in foot and ankle surgery: case-based reviews. Herbst, SA.[2014]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. [2022]

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

Liposomal Bupivacaine Versus Standard Periarticular Injection in Total Knee Arthroplasty With Regional Anesthesia: A Prospective Randomized Controlled Trial. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. [2019]

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

Local infiltration of liposome bupivacaine in orthopedic trauma patients: case-based reviews. [2022]

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

Does Liposomal Bupivacaine (Exparel) Significantly Reduce Postoperative Pain/Numbness in Symptomatic Teeth with a Diagnosis of Necrosis? A Prospective, Randomized, Double-blind Trial. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Evaluation of DepoFoam(®) bupivacaine for the treatment of postsurgical pain. [2014]

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

Local infiltration of liposome bupivacaine in foot and ankle surgery: case-based reviews. [2014]