Exparel vs. Bupivacaine for Postoperative Pain After Hernia Surgery
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.12345Why 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.24678
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo minimally invasive ventral or inguinal hernia repair with a TAP block using either Exparel or Marcaine
Post-operative Monitoring
Participants complete VAS pain assessments and record narcotic use at home, with daily follow-up calls from the study team
Follow-up
Participants return for a follow-up visit to provide VAS assessments and unused narcotics
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?
2
Treatment groups
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Leslie Son
Lead Sponsor
Our Lady of the Lake Hospital
Collaborator
Our Lady of the Lake Regional Medical Center
Collaborator
Citations
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.
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 ...
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, ...
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 ...
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 ...
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): ...
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 ...
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 ...
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