BDE for Hernia PatientsPhase 2NCT07518238
Hernia Abd Wall Recons - BDE vs Exparel
A Phase 2 study testing BDE Injectable Drug and Exparel Injectable Drug in people with BDE for Hernia Patients and Exparel for Hernia Patients, run by Baylor Research Institute at 1 site in United States.
Trial summary
This trial compares how two different numbing medications help patients feel the least amount of pain while recovering from surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- BDE for Hernia Patients, Exparel for Hernia Patients
- What is being tested?
- BDE Injectable Drug and Exparel Injectable Drug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2026to 12 Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any preoperative robotic and open abdominal wall surgery patient who will receive a transversus Abdominis Plane (TAP) block in the BSW health care system who agrees to participate in the study
- Patients 18 years and above
Who cannot join
- Patients not undergoing abdominal wall reconstruction surgery
- Pregnant patients- Patients with childbearing potential undergo serum pregnancy test as per standard of care pre-procedure. If they are found to test positive, they will be excluded from the study.
- Patients less than 18 years old
- Patients receiving any additional regional anesthesia outside the study protocol prior to surgery.
- Patients undergoing additional planned surgical procedures during the same admission
- History of chronic pain or chronic opioid use Known allergy to BDE or Exparel or to drugs included as part of multimodal regimen { acetaminophen, gabapentin or Lyrica (pregabalin)}.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: Comparative Effectiveness of Bupivacaine-Dexamethasone-Epinephrine Versus Exparel in Postoperative Outcomes for Hernia Patients Undergoing Abdominal Wall Reconstruction
This trial compares how two different numbing medications help patients feel the least amount of pain while recovering from surgery.
Read the detailed description
This will be a prospective randomized controlled trial comparing the outcomes of hernia patients receiving BDE versus Exparel before abdominal wall reconstruction. The study will utilize the pain numeric rating scale (PNRS) validated questionnaire to assess pain levels. Patients will be asked to report their worst pain imaginable.
- Being tested
- BDE Injectable Drug, Exparel Injectable Drug
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BDE Injectable DrugDrug
Bupivacaine, Dexamethasone, Epinephrine for hernia patients receiving abdominal wall reconstruction
Exparel Injectable DrugDrug
Exparel for hernia patients receiving abdominal wall reconstruction
| Study group | Role | What they receive |
|---|---|---|
| BDE for hernia patients | Active comparator | 112.5 mg of bupivacaine, 3mg dexamethasone and 0.15 mg of epinephrine. In a 30mL syringe. This will be administered into the transversus abdominis plane on both sides. Receives: Drug: BDE Injectable Drug |
| Exparel for hernia patients | Active comparator | 266mg (20ml) mixed with 30 mls of 0.25% marcaine, administered via syringe in the transversus abdominis plane on both sides. Receives: Drug: Exparel Injectable Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Milligram Equivalent
To evaluate the difference in medication usage/ Morphine Milligram Equivalent (MME) between the two groups
Measured: Post-Op day 1, 2, 3, 4 and 2 Week Follow-up (Day 14)
Pain control
Compre efficacy in pain control by using the PNRS Questionniare
Measured: Baseline, Surgery Day, Post-Op day 1, 2, 3, 4 and 2 Week Follow-up (Day 14)
Hospital Stay
To compare the length of hospital, stay between patients receiving BDE and those receiving Exparel.
Measured: 30-45 days after hospital discharge
Secondary outcomes (2)
Bowel Function
To assess the time to return of bowel function in both groups.
Measured: 30-45 days after hospital discharge
Total Cost
To compare the total cost between the two groups.
Measured: 30-45 days after hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start13 Jan 2026
- Primary completion12 Nov 2029 (estimated)
- Study completion12 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BDE for Hernia PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bola Aladegbami, MD, Principal investigator, Baylor Scott and White Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518238
- Sponsor's protocol ID
- 025-448
- Status last verified
- Mar 2026
- First submitted
- 2 Apr 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Bupivacaine-Dexamethasone-Epinephrine Versus Exparel in Postoperative Outcomes for Hernia Patients Undergoing Abdominal Wall Reconstruction
- ClinicalTrials.gov ID
- NCT07518238
- Acronym / sponsor ID
- 025-448
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 12 Nov 2029 (estimated)
- Study completion
- 12 Nov 2029 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial compares how two different numbing medications help patients feel the least amount of pain while recovering from surgery.
Detailed description
This will be a prospective randomized controlled trial comparing the outcomes of hernia patients receiving BDE versus Exparel before abdominal wall reconstruction. The study will utilize the pain numeric rating scale (PNRS) validated questionnaire to assess pain levels. Patients will be asked to report their worst pain imaginable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BDE for hernia patients | Active comparator | Drug: BDE Injectable Drug112.5 mg of bupivacaine, 3mg dexamethasone and 0.15 mg of epinephrine. In a 30mL syringe. This will be administered into the transversus abdominis plane on both sides. |
| Exparel for hernia patients | Active comparator | Drug: Exparel Injectable Drug266mg (20ml) mixed with 30 mls of 0.25% marcaine, administered via syringe in the transversus abdominis plane on both sides. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any preoperative robotic and open abdominal wall surgery patient who will receive a transversus Abdominis Plane (TAP) block in the BSW health care system who agrees to participate in the study
- Patients 18 years and above
Key exclusion criteria (6 listed)
- Patients not undergoing abdominal wall reconstruction surgery
- Pregnant patients- Patients with childbearing potential undergo serum pregnancy test as per standard of care pre-procedure. If they are found to test positive, they will be excluded from the study.
- Patients less than 18 years old
- Patients receiving any additional regional anesthesia outside the study protocol prior to surgery.
- Patients undergoing additional planned surgical procedures during the same admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BDE Injectable DrugBupivacaine, Dexamethasone, Epinephrine for hernia patients receiving abdominal wall reconstruction | Drug | BDE for hernia patients |
| Exparel Injectable DrugExparel for hernia patients receiving abdominal wall reconstruction | Drug | Exparel for hernia patients |
Primary outcome
Morphine Milligram Equivalent
Time frame: Post-Op day 1, 2, 3, 4 and 2 Week Follow-up (Day 14)
To evaluate the difference in medication usage/ Morphine Milligram Equivalent (MME) between the two groups
Pain control
Time frame: Baseline, Surgery Day, Post-Op day 1, 2, 3, 4 and 2 Week Follow-up (Day 14)
Compre efficacy in pain control by using the PNRS Questionniare
Hospital Stay
Time frame: 30-45 days after hospital discharge
To compare the length of hospital, stay between patients receiving BDE and those receiving Exparel.
2 secondary outcomes
Bowel Function
Time frame: 30-45 days after hospital discharge
Total Cost
Time frame: 30-45 days after hospital discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bola Aladegbami, MD principal investigator
Baylor Scott and White Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BDE Injectable Drug and Exparel Injectable Drug in people with BDE for Hernia Patients and Exparel for Hernia Patients, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morphine Milligram Equivalent (time frame: Post-Op day 1, 2, 3, 4 and 2 Week Follow-up (Day 14)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.