45 Participants NeededMy employer runs this trial

Liposomal vs Standard Bupivacaine for Postoperative Pain

MW
SK
Overseen BySara Kukuljan, BS, RN
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which pain medication, liposomal bupivacaine or standard bupivacaine, more effectively reduces pain after nose surgery. By comparing these two options, researchers hope to identify the best method to enhance patient comfort and speed up recovery after rhinoplasty. Individuals undergoing open nose surgery, whether for cosmetic or functional reasons, and who do not have chronic pain conditions, may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings.

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

Previous studies have shown that liposomal bupivacaine is generally safe for patients, with most participants not experiencing serious side effects. Research indicates that it reduces pain and the need for opioids after surgery, decreasing reliance on strong painkillers, which is beneficial.

Standard bupivacaine, a well-known local anesthetic, has been used safely for many years to manage pain during and after surgery. It numbs specific areas to prevent pain signals from reaching the brain.

Both treatments are considered safe based on past research. While liposomal bupivacaine provides longer-lasting pain relief, standard bupivacaine also maintains a strong safety record.12345

Why are researchers excited about this trial's treatments?

Liposomal bupivacaine is unique because it uses a liposomal delivery system that allows for a slow and sustained release of the anesthetic. This means it can potentially provide longer-lasting pain relief compared to standard bupivacaine, which is the usual go-to for postoperative pain management. Researchers are excited about this treatment since it could reduce the need for additional pain medications after surgery, offering a promising alternative for patients seeking effective and prolonged pain control.

What evidence suggests that this trial's treatments could be effective for reducing pain after nose surgery?

This trial will compare the effectiveness of liposomal bupivacaine with standard bupivacaine for managing postoperative pain. Studies have shown that liposomal bupivacaine can be more effective in managing pain after surgery than regular bupivacaine. The liposomal form releases the drug slowly over time, providing longer-lasting pain relief. This slow release maintains a steady level of medication in the body, potentially reducing the need for additional pain medications. In previous research, patients reported less pain and required fewer opioids for pain control after surgery when using liposomal bupivacaine. While regular bupivacaine works well for short-term pain, liposomal bupivacaine might offer longer relief, which can be especially helpful after surgeries like rhinoplasty. Participants in this trial will receive either liposomal bupivacaine or standard bupivacaine to assess their effectiveness in postoperative pain management.678910

Who Is on the Research Team?

MW

Matthew Wu, MD

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for people who are having nose surgery (rhinoplasty) and want to help find the best way to manage pain after their operation. Specific inclusion or exclusion criteria were not listed.

Inclusion Criteria

I am 18 or older and having open rhinoplasty surgery.

Exclusion Criteria

I have used opioid pain medication for 3 months or longer.
I am allergic or cannot take certain pain or anti-inflammatory medicines.
I am scheduled for another surgery at the same time, not involving my nose.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Liposomal Bupivacaine or Standard Bupivacaine as nerve blocks during rhinoplasty surgery

Surgery day
1 visit (in-person)

Immediate Postoperative Monitoring

Participants' pain levels and opioid consumption are monitored for the first 72 hours post-surgery

3 days

Follow-up

Participants are monitored for pain relief, side effects, and recovery progress

4 weeks
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Liposomal Bupivacaine
  • Standard Bupivacaine

Trial Overview

The study compares two types of numbing medications—standard bupivacaine and a longer-lasting version called liposomal bupivacaine—to see which works better at reducing pain after rhinoplasty.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Liposomal BupivacaineExperimental Treatment1 Intervention
Group II: Standard BupivacaineActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Citations

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Clinical outcomes of liposomal and conventional bupivacaine ...

Postoperatively, the LB group demonstrated superior short-term analgesia, with significantly lower static and dynamic VAS scores at 6 and 24 h ...

Liposomal Bupivacaine in Managing Postoperative Pain ...

The use of LB as part of a multimodal approach to postoperative pain results in diminished use of opioids, reduced pain, and decreased length ...

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Findings In this randomized clinical trial including 280 participants, no significant difference in pain control was observed between liposomal ...