Liposomal Bupivacaine vs. Bupivacaine with Epinephrine for Postoperative Pain

Overseen By Mikayla Flowers, MA

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

Trial Summary

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.

What data supports the effectiveness of the drug Liposomal Bupivacaine for postoperative pain?

Research shows that liposomal bupivacaine, which is a form of bupivacaine that lasts longer in the body, can help reduce pain after surgery and decrease the need for other pain medications like opioids. It has been found to be effective in various surgical settings, including burn patients, and may lead to shorter hospital stays and increased patient satisfaction. ^{1 2 3 4 5}

Is liposomal bupivacaine safe for use in humans?

Liposomal bupivacaine has been shown to be safe in studies involving burn patients, with no significant differences in adverse events compared to traditional pain management methods. ^{3 4 5 6 7}

What makes liposomal bupivacaine unique for postoperative pain management?

Liposomal bupivacaine is unique because it uses a special formulation that releases the drug slowly over time, providing longer-lasting pain relief compared to regular bupivacaine. This can lead to less need for additional pain medications and potentially shorter hospital stays. ^{2 5 6 8 9}

What is the purpose of this trial?

A randomized controlled trial (RCT) investigating whether the local anesthetic injection of liposomal bupivacaine during posterior spinal fusion (PSF) for AIS is more effective in reducing acute postoperative opioid consumption compared to an equal volume injection of 0.25% bupivacaine with epinephrine for patients aged 10 to 17, with 128 patients randomly assigned to one of two arms: liposomal bupivacaine or 0.25% bupivacaine with epinephrine.

Research Team

Craig Birch, MD

Principal Investigator

Boston Children's Hospital

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

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

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine and clinical outcomes. [2022]

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

Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A prospective analysis describing the innovative use of liposomal bupivacaine in burn patients. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Liposomal bupivacaine peripheral nerve block for the management of postoperative pain. [2022]

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

Bupivacaine liposomal versus bupivacaine: comparative review. [2021]

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

Serum Bupivacaine Concentration After Periarticular Injection With a Mixture of Liposomal Bupivacaine and Bupivacaine HCl During Total Knee Arthroplasty. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Bupivacaine Versus Liposomal Bupivacaine For Pain Control. [2018]

9. Canada pubmed.ncbi.nlm.nih.gov

Liposomal versus plain bupivacaine for pain control following vaginal reconstruction. [2023]