BDE vs Exparel for Hernia Pain Relief

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 explores which of two numbing medications, BDE or Exparel, better reduces pain after hernia surgery. BDE combines bupivacaine, dexamethasone, and epinephrine, while Exparel consists of a long-lasting anesthetic with marcaine. The trial aims to help patients experience less pain during recovery. Ideal participants are those planning to undergo robotic or open abdominal wall surgery and will receive a specific pain-relief injection called a TAP block.

As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to advancements in pain management.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have a history of chronic pain or use opioids regularly, you may not be eligible to participate.

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

Previous studies have shown that BDE, a combination of bupivacaine, dexamethasone, and epinephrine, is well-tolerated. Research indicates that adding dexamethasone to bupivacaine can help control pain and increase comfort after surgery. Patients using this combination reported less pain and required fewer additional pain medications.

Exparel, another option for pain relief, has also undergone extensive study. Studies have demonstrated that Exparel is safe and effective for reducing post-surgical pain. It often reduces the need for additional painkillers, including opioids.

Both treatments have proven safe and effective for managing pain. The studies reviewed reported no major side effects, suggesting both treatments are generally well-tolerated by patients.12345

Why are researchers excited about this trial's treatments?

BDE is unique because it combines bupivacaine, dexamethasone, and epinephrine in a single formulation, offering a potentially enhanced and prolonged pain relief for hernia patients. Unlike standard treatments that often involve separate administration of these components, BDE delivers them together directly into the transversus abdominis plane, which might improve the effectiveness and duration of pain control. Researchers are particularly excited about this innovative approach because it could reduce the need for opioid painkillers, offering a safer alternative for managing post-surgical pain.

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

This trial will compare BDE and Exparel for pain relief in hernia patients. Research has shown that BDE, a combination of bupivacaine, dexamethasone, and epinephrine, reduces post-surgical pain. Participants receiving BDE may experience less pain and require fewer additional pain medications, indicating effective pain management and improved patient satisfaction after hernia surgery.

For those in the Exparel arm, studies have demonstrated that Exparel reduces post-surgical pain and decreases the need for opioids, which are strong pain-relieving drugs. Participants using Exparel may report less pain and reduced narcotic use in the first 72 hours after surgery. These findings suggest that Exparel effectively provides pain relief after hernia surgeries.14678

Who Is on the Research Team?

BA

Bola Aladegbami, MD

Principal Investigator

Baylor Scott and White Health

Are You a Good Fit for This Trial?

This trial is for adults (18 and older) having robotic or open abdominal wall surgery at BSW who will get a TAP block for pain relief and agree to join the study.

Inclusion Criteria

I am having abdominal wall surgery and will get a TAP block.
I am 18 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either BDE or Exparel before abdominal wall reconstruction surgery

Surgery Day
1 visit (in-person)

Post-Operative Monitoring

Participants are monitored for pain control and medication usage using the PNRS questionnaire

4 days
Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including pain control and medication usage

2 weeks
1 visit (in-person)

Extended Follow-up

Participants are assessed for hospital stay duration, bowel function, and total cost

30-45 days after hospital discharge

What Are the Treatments Tested in This Trial?

Interventions

  • BDE
  • Exparel

Trial Overview

The study compares two injectable numbing drugs, BDE and Exparel, given during surgery to see which one better reduces pain after hernia repair. Patients are randomly assigned to receive either drug.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: BDE for hernia patientsActive Control1 Intervention
Group II: Exparel for hernia patientsActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials
210
Recruited
205,000+

Citations

Efficiency of bupivacaine and association with ... - PMC

The addition of dexmedetomidine to bupivacaine on TAP block decreased postoperative pain scores and morphine consumption; it also increased patient satisfaction ...

Dexamethasone and Bupivacaine for Pain After Hernia ...

Patients who received dexamethasone and bupivacaine reported lower pain scores, needed less extra pain medicine, and were more satisfied with ...

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 additional ...

the effect of dexamethasone on the duration of

For 0.5% ropivacaine or bupivacaine, the usual local anesthetics, previous studies report an average analgesic duration of 11 hours without epinephrine9 and ...

The Analgesic Efficacy of Low Dose Dexamethasone ...

Results: The mean time of analgesic duration in group C (3.6±3.8 hr) was greater than group D (1.6±1.14 hr). This difference was statistically ...

Effect of adding dexamethasone to bupivacaine on...

The current study showed that the addition of 8 mg dexamethasone to 20 mL bupivacaine 0.25% for TAP block on both sides resulted in a significant reduction of ...

Epidural Dexamethasone for Postoperative Analgesia ... - PMC

This study showed that adding dexamethasone to bupivacaine significantly prolongs the duration of postoperative analgesia.

Effect of topical dexamethasone and bupivacaine ...

This study was conducted to evaluate the effectiveness of the combination of dexamethasone and bupivacaine, applied locally to the surgical site ...