Liposomal Bupivacaine for Bowel Surgery Pain Management

(TAPLIP Trial)

Overseen By Edmund Takata

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Hartford Hospital

Must not be taking: Antithrombotics, Long opioids

Disqualifiers: Metastatic cancers, Coagulopathy, Substance abuse, others

Stay on Your Current Meds You can continue your current medications while participating

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: Immediate perioperative period

114 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing pain in patients undergoing laparoscopic colectomy, a specific type of bowel surgery. It compares two treatments: one uses liposomal bupivacaine, a special form of bupivacaine that releases slowly, and the other uses regular bupivacaine with additional medications. The trial aims to determine which treatment better controls post-surgery pain. Individuals planning to undergo this surgery, who do not have certain medical conditions such as a history of allergies to local anesthetics or ongoing substance abuse issues, might be suitable candidates. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand its benefits for more patients, offering participants a chance to contribute to broader medical knowledge.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on antithrombotic medications or long-acting opioids. It's best to discuss your specific medications with the trial team.

What is the safety track record for these treatments?

Research has shown that liposomal bupivacaine, also known as Exparel, has been studied for post-surgical pain relief. Some studies suggest it can lessen pain and reduce the need for strong painkillers like opioids for up to 72 hours. However, other research found it wasn't more effective than regular bupivacaine. Overall, liposomal bupivacaine is generally well-tolerated by patients.

Regular bupivacaine is a common pain relief drug used in surgeries. It is usually safe when used properly, though, like any medication, it can have rare side effects.

Both treatments have undergone extensive study and are considered safe for humans. Patients should always consult their doctor to understand what this means for them personally. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for pain management after bowel surgery, like standard bupivacaine, work to numb the area temporarily. But liposomal bupivacaine is unique because it uses a special delivery system that releases the drug slowly over time. This means it can provide longer-lasting pain relief, potentially reducing the need for additional pain medications. Researchers are excited about this treatment because it could improve recovery by managing pain more effectively and reducing reliance on opioids.

What evidence suggests that this trial's treatments could be effective for bowel surgery pain management?

This trial will compare liposomal bupivacaine, sold as Exparel, with regular bupivacaine for pain management after bowel surgery. Studies have shown that liposomal bupivacaine can provide longer pain relief after surgery and is approved for use as a single dose to help manage pain. One study found that this long-lasting form of bupivacaine reduced the need for opioids after surgeries like bunion removal. However, other research suggests that liposomal bupivacaine might not control pain better than regular bupivacaine. Regular bupivacaine effectively reduces pain after surgery, but its effects don't last as long as the liposomal version. Overall, while liposomal bupivacaine shows promise for longer-lasting pain relief, its effectiveness can vary based on the type of surgery and individual patient response. ^{1 2 3 4 5}

Who Is on the Research Team?

Kevin J Finkel, MD

Principal Investigator

Hartford Hospital

Are You a Good Fit for This Trial?

This trial is for English-speaking patients scheduled for elective laparoscopic colectomy with an ASA score I-IV. Excluded are those with emergency surgery, metastatic cancers, planned multi-organ resection, TAP block contraindications like anatomical abnormalities or infection at the injection site, current colostomies, severe coagulation disorders, underweight (<40kg), chronic opioid use or substance abuse within 3 months.

Inclusion Criteria

I am scheduled for a specific colon surgery by a study surgeon.

Patients with American Society of Anesthesiology (ASA) physical status score I- IV

Exclusion Criteria

I had emergency surgery to remove part of my colon.

I weigh less than 40 kg.

I am scheduled for surgery to remove multiple organs, including part of my colon.

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 regular bupivacaine in TAP blocks during laparoscopic colectomy procedures

Immediate perioperative period

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for pain scores, opioid consumption, and nausea/vomiting for up to 6 days post-surgery

6 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including block complications and overall satisfaction

30 days

1 visit (in-person or phone call)

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine HCL
• Liposomal Bupivicaine/Bupivacaine Admixture

Trial Overview The study compares liposomal bupivacaine (Exparel) to regular bupivacaine in bilateral mid-abdominal TAP blocks during laparoscopic colectomy. It's a single-center trial where participants are randomly assigned and triple-blinded to determine which medication provides better pain control.

How Is the Trial Designed?

Group I: Liposomal Bupivacaine/Bupivacaine HCL Experimental Treatment 2 Interventions

20mL 1.3% Exparel (266mg) + 60mL 0.25% bupivacaine (150mg) + 20mL normal saline. Total 100mL divided into 10mL syringes, 30 mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.

Group II: Regular Bupivacaine Arm Active Control 1 Intervention

80mL 0.25% bupivacaine (200mg) + 300mcg (0.3mL) epinephrine + 5mg (0.5mL) preservative free dexamethasone + 20mL of normal saline. Total 100mL divided into 10mL syringes, 30mL left TAP, 30mL right TAP, 20mL left rectus, 20mL right rectus.

Who Is Running the Clinical Trial?

Hartford Hospital

Lead Sponsor

Trials

140

Recruited

19,700+

Published Research Related to This Trial

Liposomal bupivacaine (LB) is safe for use in pediatric patients and significantly improves pain control after pharyngoplasty, as evidenced by lower pain scores compared to those receiving standard lidocaine.

Patients treated with LB had earlier oral intake, required fewer opioids, and were discharged from the hospital nearly 2 days earlier than those in the control group, highlighting its efficacy in postoperative recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended Release Liposomal Bupivacaine Injection (Exparel) for Early Postoperative Pain Control Following Pharyngoplasty. Day, KM., Nair, NM., Griner, D., et al.[2018]

In a retrospective analysis of 575 subjects across 6 clinical trials, liposome bupivacaine showed a similar safety profile to both bupivacaine HCl and normal saline, with 76% of liposome bupivacaine recipients experiencing adverse events (AEs).

The most common AEs for liposome bupivacaine included nausea and hypesthesia, and serious AEs occurred in 8% of subjects, indicating that the side effects are likely related to the surgical procedure rather than the medication itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Ilfeld, BM., Viscusi, ER., Hadzic, A., et al.[2022]

DepoFoam bupivacaine, an extended-release formulation of the local anesthetic bupivacaine, provides effective pain relief for 3-4 days after a single administration at the surgical site, reducing the need for opioid pain relief.

The safety profile of DepoFoam bupivacaine is comparable to traditional bupivacaine HCl, with adverse events being dose-related, indicating it is a safe option for managing postsurgical pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of DepoFoam(®) bupivacaine for the treatment of postsurgical pain. Bergese, SD., Onel, E., Portillo, J.[2014]

In a study involving 98 mice, liposomal bupivacaine (Exparel®) provided a longer duration of pain relief compared to standard bupivacaine, with motor block lasting up to 180 minutes and thermoalgesic block lasting up to 420 minutes.

The addition of dexamethasone, either perineurally or systemically, significantly reduced neural inflammation caused by bupivacaine, and perineural dexamethasone also helped reduce inflammation from Exparel®, suggesting a protective effect against nerve damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perineural dexamethasone attenuates liposomal bupivacaine-induced delayed neural inflammation in mice in vivo. Ferré, F., Krin, A., Sanchez, M., et al.[2020]

In a pilot study involving 25 pigs, subarachnoid administration of liposomal bupivacaine resulted in a longer duration of pain relief compared to standard bupivacaine hydrochloride, with effects lasting up to 32 hours for higher doses.

No signs of neurotoxicity were observed in any treatment group, suggesting that liposomal bupivacaine may be a safe option for extended analgesia in the neuraxial space, warranting further studies for potential human use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurological and histological outcomes after subarachnoid injection of a liposomal bupivacaine suspension in pigs: a pilot study. Zel, J., Hadzic, A., Cvetko, E., et al.[2019]

Exparel™ (DepoFoam bupivacaine) provides a longer-lasting nerve blockade (240 minutes) compared to standard bupivacaine solutions, which lasted 120 minutes and 210 minutes, indicating its potential for improved pain management.

While Exparel™ showed slightly higher inflammation scores than standard bupivacaine solutions shortly after injection, it had similar myotoxicity levels and no neurotoxicity, suggesting it may be a safe option for local anesthesia, though monitoring for tissue reactions is recommended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multivesicular liposomal bupivacaine at the sciatic nerve. McAlvin, JB., Padera, RF., Shankarappa, SA., et al.[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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3772762/

Liposomal extended-release bupivacaine for postsurgical ... In this brief review, we provide an update of the current knowledge in the use of bupivacaine for postsurgical analgesia. Keywords: bupivacaine, liposome, ...

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. clinicaltrials.gov clinicaltrials.gov/study/NCT02969187

Bupivacaine Liposomal Injection (Exparel) for Postsurgical ... Bupivacaine should reduce postoperative pain but it has relatively shorter duration of action. Liposome bupivacaine (Exparel) has been approved as a single dose ...

5. aetna.com aetna.com/cpb/medical/data/900_999/0941.html

Bupivacaine Liposome (Exparel) - Medical Clinical Policy ... The authors concluded that DepoFoam bupivacaine, a long-acting local analgesic, provided extended pain relief and decreased opioid use after bunionectomy, ...