Liposomal Bupivacaine for Lumbar Spinal Stenosis

Overseen By Akal Sethi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Must not be taking: Opioids

Disqualifiers: Pregnant, Breastfeeding, Prisoners, 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 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 2 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called liposomal bupivacaine, a type of local anesthetic, for individuals with lumbar spinal stenosis. This condition involves the narrowing of spaces in the lower spine, which can cause pain. The researchers aim to determine if this treatment can reduce hospital stays, lessen the need for painkillers, and improve recovery after back surgery. Participants will receive either liposomal bupivacaine or a standard local anesthetic for comparison. Suitable candidates for this trial have lumbar spinal stenosis and are planning to undergo surgery. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. However, if you use more than 25 morphine equivalents of opioids daily, you cannot participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that liposomal bupivacaine (LB) is generally safe and can help manage pain after spine surgeries. Studies have found that LB reduces the need for pain medicine and may lead to shorter hospital stays after back surgery. These studies have reported no major serious side effects, suggesting LB is safe for these procedures. While the current trial is ongoing, earlier research supports its safety in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for lumbar spinal stenosis?

Liposomal Bupivacaine is unique because it offers a new delivery method for managing lumbar spinal stenosis pain. Unlike traditional local anesthetics that provide short-term relief, liposomal bupivacaine releases its active ingredient gradually over time, potentially extending pain relief and reducing the need for frequent dosing. Researchers are excited about this treatment because it could improve patient comfort and recovery by maintaining consistent pain control with fewer side effects.

What evidence suggests that liposomal bupivacaine might be an effective treatment for lumbar spinal stenosis?

Research has shown that liposomal bupivacaine, which participants in this trial may receive, can reduce the need for opioids after surgery. One study found that patients using liposomal bupivacaine required fewer opioids post-operation, aiding in pain management. Another study demonstrated that it can also shorten the hospital stay after lumbar spine surgery, allowing patients to recover faster and go home sooner. Overall, liposomal bupivacaine shows promise in easing pain after lumbar surgeries and improving recovery times. This trial will compare liposomal bupivacaine with a standard local anesthetic to evaluate its effectiveness. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults over 18 with lumbar spinal stenosis who haven't had previous surgery at the affected level and don't require a fusion procedure. It's not for those under 18, pregnant or breastfeeding individuals, prisoners, patients with daily high-dose opioid use, or if there are other health issues that make surgery too risky.

Inclusion Criteria

Anyone can participate regardless of gender.

Adult (≥18 yo)

You have a condition called lumbar stenosis.

Exclusion Criteria

≤18 yo

Previous lumbar surgery at indicated level

You are currently pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo lumbar laminectomies with either liposomal bupivicaine or standard local anesthetic

Up to 2 weeks

Inpatient stay

Follow-up

Participants are monitored for narcotic usage, pain levels, and readmission rates

30 days

1 visit (in-person), additional assessments via electronic medical records

Long-term follow-up

Participants' pain levels are assessed up to 12 months post-operation

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Liposomal Bupivacaine

Trial Overview The trial is testing whether liposomal bupivacaine can improve outcomes after lumbar laminectomy surgeries. It looks at how long patients stay in the hospital, their need for IV and oral narcotics post-surgery, pain levels using VAS scores, and readmission rates within 30 days.

How Is the Trial Designed?

Group I: Liposomal Bupivicaine Active Control 1 Intervention

Treatment with liposomal bupivicaine

Group II: Standard Local Anesthestic Active Control 1 Intervention

Treatment with Standard Local Anesthestic

Liposomal Bupivacaine is already approved in United States for the following indications:

Approved in United States as EXPAREL for:

• Postsurgical local analgesia via infiltration in adults
• Regional analgesia via interscalene brachial plexus nerve block in adults

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6159630/

The Efficacy of Liposomal Bupivacaine in Lumbar Spine ... Our results indicate that the use of LB in patients who are narcotic tolerant at the time of surgery may reduce the total postoperative opioid requirement.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10158925/

Clinical Outcomes of Liposomal Bupivacaine Erector ... Postoperative pain is a barrier to early mobility and discharge after lumbar surgery. Liposomal bupivacaine (LB) has been shown to decrease ...

3. journalmsr.com journalmsr.com/does-liposomal-bupivacaine-reduce-hospital-length-of-stay-for-multilevel-lumbar-decompressions-a-retrospective-matched-cohort-study/

Does liposomal bupivacaine reduce hospital length of stay ... LB, as local infiltration at the end of a multilevel lumbar decompression, is an effective tool to decrease post-operative pain and shorten hospital stay.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03745040

Study Details | NCT03745040 | Liposomal Bupivacaine in ... This study will describe postoperative pain management for spine surgery patients receiving liposomal bupivacaine (Exparel®) compared to patients not receiving ...

5. thespinejournalonline.com thespinejournalonline.com/article/S1529-9430(24)00258-4/fulltext

Effects of liposomal bupivacaine on opioid use and ... This study investigated the association between liposomal bupivacaine (LB) and outpatient spine surgery outcomes, including perioperative, postoperative, and ...