Bupivacaine vs. Liposomal Bupivacaine for Postoperative Pain

Overseen By Roberta Johnson

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: The Cleveland Clinic

Must not be taking: Morphine

Disqualifiers: Pregnancy, Infection, Liver disease, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two methods for managing post-surgery pain using bupivacaine anesthesia. One group will receive bupivacaine mixed with a new, longer-lasting version called liposomal bupivacaine, while the other group will receive regular bupivacaine with a saline solution. The trial aims to determine which method provides better pain relief after surgeries like lung removal or similar procedures. Individuals who have undergone thoracic surgery using small incisions, such as video-assisted or robotic lung surgeries, may be suitable candidates for this trial. As an Early Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants a chance to contribute to innovative pain management strategies.

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

The trial information does not specify if you need to stop taking your current medications. However, if you are taking more than 15 mg/day of morphine equivalents regularly, you may not be eligible to participate.

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

Research shows that bupivacaine is generally well-tolerated by patients. Some studies have found it helps manage pain after surgery, especially for procedures lasting more than 40 minutes. Reports of serious side effects from bupivacaine are rare.

For liposomal bupivacaine, studies suggest it is safe and may reduce pain and the need for painkillers like opioids. Research has shown that patients using liposomal bupivacaine reported lower pain levels and used fewer opioids. However, some studies did not find a significant difference in pain control compared to regular bupivacaine.

Both treatments have demonstrated a good safety record in the studies mentioned, suggesting they are likely safe options for managing pain after surgery. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about liposomal bupivacaine because it may offer longer-lasting pain relief after surgery compared to traditional bupivacaine. Unlike standard bupivacaine, liposomal bupivacaine uses a special delivery system that slowly releases the drug over time, potentially reducing the need for additional pain medication. This extended-release mechanism is particularly promising because it could enhance patient comfort and speed up recovery, making it an innovative option for managing postoperative pain.

What evidence suggests that this trial's treatments could be effective for postoperative pain?

This trial will compare Bupivacaine with Liposomal Bupivacaine for managing postoperative pain. Research has shown mixed results for both treatments. Standard Bupivacaine, administered to participants in one arm of this trial, works for about 8 hours. Some studies found it might not significantly reduce pain or the need for painkillers unless the surgery lasts more than 40 minutes. Liposomal Bupivacaine, given to participants in another arm, is designed to last up to 3 days. However, studies have found it doesn't always provide better pain relief than the standard version. Some research suggests Liposomal Bupivacaine might reduce opioid use and shorten hospital stays, though other studies found no significant difference in pain control. Overall, both treatments have their pros and cons, and their effectiveness can vary. ^{1 2 6 7 8}

Who Is on the Research Team?

Alparslan Turan, MD

Principal Investigator

The Cleveland Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-85 undergoing certain thoracic surgeries like VATS or robotic pulmonary resection. Candidates must not be on high doses of opioids, have active liver disease, pacemakers or implants near the surgery site, weigh under 50 kg, be pregnant or breastfeeding, require emergency surgery from ICU, have severe kidney issues, infections, uncontrolled psychiatric disorders or known allergies to local anesthetics.

Inclusion Criteria

I have had lung surgery using small cuts or robotic assistance.

Exclusion Criteria

Previous participation in this study

Poorly controlled psychiatric disorders

I was moved from the ICU to the operating room for emergency surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive PECSII and serratus anterior plane blocks with either bupivacaine HCl plus liposomal bupivacaine or bupivacaine HCl plus saline

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of analgesia score

3 days

Postoperative day 3 assessment

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine
• Liposomal Bupivacaine

Trial Overview The study compares pain management in thoracic surgery patients using two types of blocks: one with bupivacaine HCl and liposomal bupivacaine (treatment group) versus bupivacaine HCl with saline (control group). Participants are randomly assigned to groups and outcome assessments are done by researchers unaware of which group each patient is in.

How Is the Trial Designed?

Group I: Bupi HCl plus liposomal bupi Experimental Treatment 1 Intervention

PECSII/SAP blocks with bupivacaine HCl plus liposomal bupivacaine

Group II: Bupi HCl plus saline Active Control 1 Intervention

PECSII/SAP blocks with bupivacaine HCl plus preservative free normal saline

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in European Union as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+

Citations

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

Standard vs Liposomal Bupivacaine for Postoperative Pain ... Findings In this randomized clinical trial including 280 participants, no significant difference in pain control was observed between liposomal ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33724391/

Effectiveness of Standard Local Anesthetic Bupivacaine and ... Importance: Liposomal bupivacaine for pain relief is purported to last 3 days compared with 8 hours with standard bupivacaine.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7002882/

Effect of bupivacaine on postoperative pain and analgesics ... Bupivacaine did not decrease pain and analgesics use. When surgery exceeded 40 minutes, bupivacaine use might be associated with less pain and less analgesics ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06531603

Postoperative Analgesic Effectiveness of Bupivacaine With ... Postoperative Analgesic Effectiveness of Bupivacaine With and Without Dexmedetomidine in Patients With Abdominal Surgery. ClinicalTrials.gov ID NCT06531603.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949962325000105

Comparing intraoperative administration of long-acting ... This study compared postoperative pain outcomes with LB versus MCs such as ropivacaine-epinephrine-clonidine-ketorolac, bupivacaine-epinephrine-dexamethasone, ...

6. nature.com nature.com/articles/s41598-025-17790-9

Preclinical safety and feasibility of a bupivacaine-loaded ... Severe postoperative pain typically lasts for 3 days after spine surgery, and can significantly influence surgical outcomes and patient ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/17805109/

Intraoperative Sensorcaine significantly improves ... Patients treated with Sensorcaine were discharged home significantly faster (2.9 hours versus 3.8 hours, p = 0.002). The control arm ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2352587825001160

Research progress of liposomal bupivacaine and its value ... They observed that patients in the LB group reported significantly lower pain scores at both 24 and 48 h post-surgery compared to those who received ...