Liposomal Bupivacaine vs. Bupivacaine with Epinephrine for Postoperative Pain

Overseen By Sara Olenich, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Must not be taking: Opioids, Analgesics

Disqualifiers: Neuromuscular, Psychiatric, Neurological, others

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

Compensation: Varies

Number of Visits: 1

Duration: Immediate postoperative period

128 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which type of anesthesia better reduces the need for opioids after spinal surgery in teenagers with Adolescent Idiopathic Scoliosis (a type of spine curve). Researchers are comparing two treatments: liposomal bupivacaine (bupivacaine liposome injectable suspension) and regular bupivacaine with epinephrine (bupivacaine hydrochloride and epinephrine injection). Participants will receive one of these treatments during surgery to assess which one manages pain more effectively without relying on opioids. Teens aged 10 to 17 with Adolescent Idiopathic Scoliosis scheduled for spinal fusion surgery may be eligible to join. As an unphased trial, this study offers a unique opportunity to contribute to medical knowledge and potentially improve pain management for future patients.

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

The trial does not specify if you need to stop taking your current medications, but it excludes those who are on chronic pain treatments or opioids before surgery.

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

Research has shown that liposomal bupivacaine is generally safe for both children and adults after surgery. One study found that it lowered pain levels and hospital costs while reducing the need for opioids, indicating it is well-tolerated. Another study showed it did not cause more side effects than regular bupivacaine, a common pain relief drug.

Regular bupivacaine with epinephrine is widely used for pain relief, and its safety is well-established. It numbs the area, and epinephrine extends the numbing effect.

In summary, studies have shown both treatments to be safe, with no major safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments because they offer potentially better ways to manage postoperative pain after spinal surgery. Unlike the standard of care, which typically involves bupivacaine with epinephrine to prolong anesthesia effects, liposomal bupivacaine provides a unique delivery method that releases the anesthetic slowly over time. This slow-release mechanism could result in longer-lasting pain relief from a single dose, reducing the need for additional pain medication. Additionally, using liposomal technology might minimize side effects associated with high peaks of anesthetic concentration in the body.

What evidence suggests that this trial's treatments could be effective for reducing acute postoperative opioid consumption in AIS patients?

This trial will compare liposomal bupivacaine with bupivacaine with epinephrine for postoperative pain management. Studies have shown that liposomal bupivacaine does not consistently improve pain control or reduce opioid use compared to regular bupivacaine. In many trials, it did not provide better pain relief than other treatments. Conversely, bupivacaine with epinephrine effectively numbs and reduces bleeding during surgery. Although liposomal bupivacaine is designed for slow medicine release, its benefit for postoperative pain relief has not been proven in many cases. Current research does not strongly support liposomal bupivacaine as superior to standard options. ^{2 6 7 8 9}

Who Is on the Research Team?

Craig Birch, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for young patients aged 10 to 17 who are undergoing posterior spinal fusion surgery for Adolescent Idiopathic Scoliosis (AIS). It's designed to see if a new pain control method works better after surgery. Patients with certain health conditions or on medications that could interfere with the study may not be eligible.

Inclusion Criteria

I have been diagnosed with Adolescent Idiopathic Scoliosis.

I am between 10 and 17 years old.

I am scheduled for surgery to correct a worsening curve in my spine.

Exclusion Criteria

Diagnosis of neuromuscular, syndromic, or congenital scoliosis

History of known allergy to local anesthesia

Chronic pre-operative opioid consumption

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo posterior spinal fusion surgery with local infiltration of either liposomal bupivacaine or 0.25% bupivacaine with epinephrine

Immediate postoperative period

1 visit (in-person)

Postoperative Monitoring

Participants' opioid consumption and pain scores are monitored for 72 hours postoperatively

72 hours

Follow-up

Participants are monitored for pain, functional ability, and mental health scores at 1-, 6-, 12-, and 24-months postoperatively

24 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine Hydrochloride and Epinephrine Injection
• Bupivacaine liposome injectable suspension

Trial Overview The study compares two types of local anesthetic injections: liposomal bupivacaine and regular bupivacaine with epinephrine, in terms of reducing the need for opioids after spine surgery. Participants will be randomly placed into one of these two treatment groups.

How Is the Trial Designed?

Group I: Local infiltration with liposomal bupivacaine Experimental Treatment 1 Intervention

Patients randomized into the liposomal bupivacaine group will receive anesthesia and undergo standard posterior spinal fusion surgery. The local infiltration would occur in a single stage, after instrumentation and correction maneuver is performed, just prior to closure of the deep fascial layer. The dose would be injected via multiple small volume injections into the paraspinal musculature, spaced approximately 1 cm apart.

Group II: Local infiltration with 0.25% bupivacaine with epinephrine Active Control 1 Intervention

Patients randomized into the 0.25% bupivacaine with epinephrine group will receive anesthesia and undergo standard posterior spinal fusion surgery under the same condition as the intervention group with one exception: the local infiltration will be made up of equal volume of 0.25% bupivacaine with epinephrine. The equal volume of 0.25% bupivacaine with epinephrine will be used in the exact same administration technique as the liposomal bupivacaine group, involving multiple small-volume injections to the paraspinal musculature spaced approximately 1 centimeter apart.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Published Research Related to This Trial

Bupivacaine liposomal injection has been approved by the FDA as a local anesthetic for managing postsurgical pain in adults, showing significant efficacy in reducing postoperative pain and opioid use compared to placebo.

This review compares the efficacy of bupivacaine liposomal to conventional bupivacaine with or without epinephrine, utilizing both published and unpublished data submitted to the FDA by the manufacturer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine liposomal versus bupivacaine: comparative review. Noviasky, J., Pierce, DP., Whalen, K., et al.[2021]

Liposomal bupivacaine significantly extends the duration of pain relief compared to traditional bupivacaine HCL, making it a more effective option for post-operative pain management.

Clinical studies indicate that liposomal bupivacaine not only improves patient satisfaction but also reduces hospital admissions and the risk of opioid-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine For Pain Control. Beiranvand, S., Moradkhani, MR.[2018]

Liposomal bupivacaine offers a longer duration of action compared to traditional bupivacaine HCl, which can enhance postoperative pain control and potentially improve patient satisfaction.

Preliminary clinical trials indicate that liposomal bupivacaine has predictable pharmacokinetics and a similar side effect profile to bupivacaine HCl, suggesting it may reduce the need for opioids and associated adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine and clinical outcomes. Tong, YC., Kaye, AD., Urman, RD.[2022]

In a study of 50 patients undergoing vaginal reconstructive surgery, liposomal bupivacaine (LB) did not show any significant advantage over plain bupivacaine in terms of postoperative pain control, narcotic use, or length of hospital stay.

Despite LB's higher cost, the results indicate that it is not more effective than plain bupivacaine for managing pain after surgery, suggesting a need for further research to find the best pain management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal versus plain bupivacaine for pain control following vaginal reconstruction. Jensen, S., Amasyali, AS., Keheila, M., et al.[2023]

In a randomized controlled trial involving 57 patients undergoing midurethral sling placement, liposomal bupivacaine resulted in lower median pain scores on postoperative day 1 compared to a mixture of bupivacaine and lidocaine (20 mm vs 30 mm), indicating some efficacy in pain management.

Despite the initial lower pain scores, there were no significant differences in overall opioid and nonsteroidal anti-inflammatory drug consumption or in quality of recovery scores after 7 days, suggesting that liposomal bupivacaine may not provide a clinically significant advantage over traditional pain management methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liposomal Bupivacaine Versus Bupivacaine Hydrochloride with Lidocaine during Midurethral Sling Placement: A Randomized Controlled Trial. Iwanoff, C., Salamon, C.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28478185/

Effectiveness of Bupivacaine Liposome Injectable ... Conclusion: There is no benefit in the use of liposomal bupivacaine compared with ropivacaine for postoperative pain control in TKA. Trial registration: ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2777506

Standard vs Liposomal Bupivacaine for Postoperative Pain ... Liposomal bupivacaine did not provide improved pain control and did not reduce adjunctive opioid use compared with conventional bupivacaine formulation over 3 ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022480421001244

The Efficacy of Liposomal Bupivacaine for Opioid and Pain ... Liposomal bupivacaine did not demonstrate significant pain relief compared to placebo or active agents in 74.58% of RCTs.

4. journalofsurgicalresearch.com journalofsurgicalresearch.com/article/S0022-4804(21)00124-4/abstract

The Efficacy of Liposomal Bupivacaine for Opioid and Pain ... Liposomal bupivacaine did not demonstrate significant pain relief compared to placebo or active agents in 74.58% of RCTs. Of the studies ...

5. josr-online.biomedcentral.com josr-online.biomedcentral.com/articles/10.1186/s13018-023-03699-4

Liposomal bupivacaine administration is not superior to ... PMDI can effectively reduce postoperative pain, decrease the demand for systemic analgesics, and consequently decrease the side effects of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6464293/

Liposomal bupivacaine infiltration at the surgical site for the ... One study reported a lower mean pain score at 12 hours associated with liposomal bupivacaine compared to bupivacaine hydrochloride, but not at ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30521078/

Incidence of adverse events attributable to bupivacaine ... The aim of this study was to describe the incidence of local anesthetic systemic toxicity syndrome in pediatric surgical patients receiving liposomal ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2468428725000784

Liposomal bupivacaine infiltration for postprocedural ... These findings suggest that LB is safe to use for postprocedural analgesia in pediatric and adult patients undergoing painful interventions for vascular ...

9. link.springer.com link.springer.com/article/10.1007/s44254-025-00095-5

Efficacy and safety of liposomal bupivacaine administration ... The existing literature suggests that LB may reduce pain scores, hospital costs, length of hospital stay, and opioid use.