Exparel vs. Bupivacaine for Postoperative Pain After Hernia Surgery

Overseen By Christine LeBoeuf, DNP

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Leslie Son

Disqualifiers: Chronic pain, Allergy to bupivacaine, Recurrent hernias, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two pain relief options for individuals undergoing minimally invasive surgery to repair a ventral or inguinal hernia. It compares Exparel, a long-lasting version of bupivacaine, to regular bupivacaine, both used in a TAP block, a type of anesthesia that numbs the abdominal area. The goal is to determine which treatment provides better pain control after surgery. Individuals with a ventral or inguinal hernia planning surgical repair might be suitable for this trial. As an Early Phase 1 trial, this research aims to understand how these treatments work in people, offering participants the chance to contribute to groundbreaking medical knowledge.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that Liposomal Bupivacaine (Exparel) is generally safe and effective for managing post-surgical pain. Studies have found it provides longer-lasting pain relief compared to traditional methods, with rare and usually mild side effects.

For standard Bupivacaine (Marcaine), evidence supports its safety and effectiveness in reducing post-surgical pain, particularly in hernia operations. It is a reliable choice with a strong history of use, and serious side effects are uncommon.

Both options have demonstrated success in surgeries, showing good safety records and minimal side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Liposomal Bupivacaine (Exparel) because it offers a novel approach to managing postoperative pain after hernia surgery. Unlike standard treatments like Bupivacaine (Marcaine), which provide shorter-term pain relief, Exparel utilizes a unique liposomal delivery system that releases the anesthetic slowly over time. This extended-release feature could potentially offer longer-lasting pain control with a single dose, reducing the need for additional pain medication and enhancing patient comfort. By minimizing the reliance on opioids for pain management, Exparel presents a promising advancement in postoperative care.

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

This trial will compare the effectiveness of Liposomal Bupivacaine (Exparel) and traditional Bupivacaine (Marcaine) in managing postoperative pain after hernia surgery. Research has shown that traditional bupivacaine reduces pain after hernia surgery, with some studies finding that soaking the surgical mesh in bupivacaine significantly lessens pain soon after the operation. Liposomal bupivacaine (Exparel) is designed to relieve pain for up to 72 hours post-surgery. However, some research suggests it might not control pain better than regular bupivacaine. Both treatments aim to manage postoperative pain, but their effectiveness can vary depending on the specific surgery. ^{2 4 6 7 8}

Who Is on the Research Team?

Leslie Son, PhD

Principal Investigator

Our Lady of the Lake Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 with ventral or inguinal hernias needing surgery. It's not for those under 18, chronic pain patients, individuals with very large (>10 cm) or small (<4 cm) defects, allergies to bupivacaine, recurrent hernia history, emergency surgeries, other concurrent surgeries, heavy alcohol users, if the procedure turns open surgery, people weighing less than 50kg or with a BMI over 45.

Inclusion Criteria

I need surgery for a hernia in my abdomen or groin area.

Exclusion Criteria

My bupivacaine is mixed with other anesthetics.

I have had a TAP block, but not right before my procedure.

You have a defect that is smaller than 4 centimeters.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo minimally invasive ventral or inguinal hernia repair with a TAP block using either Exparel or Marcaine

1 day

1 visit (in-person)

Post-operative Monitoring

Participants complete VAS pain assessments and record narcotic use at home, with daily follow-up calls from the study team

1 week

Daily virtual follow-ups

Follow-up

Participants return for a follow-up visit to provide VAS assessments and unused narcotics

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Bupivacaine
• Liposomal Bupivacaine

Trial Overview The study tests two types of TAP blocks in minimally invasive hernia repairs: one using Exparel (Liposomal Bupivacaine), and the other using Marcaine (Bupivacaine). Patients are randomly assigned to receive either treatment to compare postoperative pain control effectiveness.

How Is the Trial Designed?

Group I: Liposomal Bupivacaine (Exparel) Active Control 1 Intervention

The bilateral TAP block will be performed by the department of anesthesia under ultrasound guidance using 20cc of local anesthetic per side. Additional local anesthetic will be supplied by the surgeon at the incision sites.

Group II: Bupivacaine (Marcaine) Active Control 1 Intervention

The bilateral TAP block will be performed by the department of anesthesia under ultrasound guidance using 20cc of local anesthetic per side. Additional local anesthetic will be supplied by the surgeon at the incision sites.

Who Is Running the Clinical Trial?

Leslie Son

Lead Sponsor

Trials

1

Recruited

200+

Our Lady of the Lake Hospital

Collaborator

Trials

15

Recruited

900+

Our Lady of the Lake Regional Medical Center

Collaborator

Trials

6

Recruited

470+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7597881/

Post-operative pain after laparoscopic ventral hernia repair ... Soakage of mesh in 0.5% bupivacaine solution before application in laparoscopic ventral hernia repair significantly reduces early post-operative pain.

2. sciencedirect.com sciencedirect.com/science/article/pii/S1098733999900512

Pain relief by wound infiltration with bupivacaine or high ... Wound infiltration with long-acting local anesthetics resulted in low pain scores after hernia surgery. Bupivacaine 100 mg was as effective as ropivacaine 300 ...

3. cureus.com cureus.com/articles/406714-effect-of-bupivacaine-soaked-polypropylene-mesh-on-postoperative-pain-in-patients-undergoing-lichtenstein-repair-for-inguinal-hernia

Effect of Bupivacaine-Soaked Polypropylene Mesh on ... Conclusion: The use of 0.5% bupivacaine-soaked mesh in Lichtenstein repair significantly reduces postoperative pain and shortens hospital stay, ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05177991

Post-operative Pain Control-TAP Block Using Exparel vs. ... While studies have shown improved postoperative pain control with TAP blocks after inguinal and ventral hernia repair, data comparing Liposomal bupivacaine ...

5. 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 ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/1948598/

The use of bupivacaine in elective inguinal herniorrhaphy ... The use of bupivacaine in elective inguinal herniorrhaphy as a fast and safe technique for relief of postoperative pain. Surg Gynecol Obstet. 1991 Dec;173(6): ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07208253?term=TREATMENt

Dexamethasone and Bupivacaine for Pain After Hernia ... Results showed that patients in the dexamethasone + bupivacaine group had significantly lower pain scores at all time points, required fewer ...

8. link.springer.com link.springer.com/article/10.1007/s12325-018-0836-4

Safety and Efficacy of Bupivacaine HCl Collagen-Matrix ... Patients who received INL-001 in both studies reported significantly lower pain intensity and opioid use through 24 h post-surgery versus those ...