128 Participants Needed

Liposomal Bupivacaine vs. Bupivacaine with Epinephrine for Postoperative Pain

SL
MF
Overseen ByMikayla Flowers, MA
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Boston Children's Hospital
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

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.34567

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.25689

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

CB

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
See 2 more

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
2Treatment groups
Experimental Treatment
Active Control
Group I: Local infiltration with liposomal bupivacaineExperimental Treatment1 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 epinephrineActive Control1 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.

Find a Clinic Near You

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

References

Liposomal Bupivacaine Versus Bupivacaine Hydrochloride with Lidocaine during Midurethral Sling Placement: A Randomized Controlled Trial. [2020]
Liposomal bupivacaine and clinical outcomes. [2022]
Bupivacaine liposome injectable suspension compared with bupivacaine HCl for the reduction of opioid burden in the postsurgical setting. [2022]
A prospective analysis describing the innovative use of liposomal bupivacaine in burn patients. [2020]
Liposomal bupivacaine peripheral nerve block for the management of postoperative pain. [2022]
Bupivacaine liposomal versus bupivacaine: comparative review. [2021]
Serum Bupivacaine Concentration After Periarticular Injection With a Mixture of Liposomal Bupivacaine and Bupivacaine HCl During Total Knee Arthroplasty. [2019]
Bupivacaine Versus Liposomal Bupivacaine For Pain Control. [2018]
Liposomal versus plain bupivacaine for pain control following vaginal reconstruction. [2023]
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