Inguinal HerniaEarly Phase 1NCT05177991
Post-operative Pain Control-TAP Block Using Exparel vs. Marcaine for Hernia Repairs
A Early Phase 1 study testing Liposomal Bupivacaine and Bupivacaine in people with Inguinal Hernia and Ventral Hernia, run by Leslie Son at 1 site in United States.
Trial summary
While studies have shown improved postoperative pain control with TAP blocks after inguinal and ventral hernia repair, data comparing Liposomal bupivacaine (Exparel) to bupivacaine alone in formulation of the TAP block is particularly scarce. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia, Ventral Hernia
- What is being tested?
- Liposomal Bupivacaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 31 Dec 2025
- Phase
- Early Phase 1
- 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
- 18 years of age or older
- Have a ventral or inguinal hernia requiring surgical repair
Who cannot join
- Less than 18 years of age
- Chronic pain patients
- Having a defect >10 cm in transverse dimension
- Having a defect <4 cm
- Has an allergy to bupivacaine
- Has recurrent hernias as per medical history
Show all 15Show fewer
- A TAP block performed at any time aside from just prior to the start of the procedure
- If bupivacaine is mixed with other anesthetics
- Under the instance of an emergency surgery (trauma)
- Concomitant surgery
- History of EtOH abuse
- History of liver/kidney dysfunction
- If the procedure must be converted to open
- Inidividual's weight < 50kg
- Individual's BMI > 45
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Evaluation of Post-operative Pain Control With a TAP Block Using Exparel vs. Marcaine for Hernia Repairs
While studies have shown improved postoperative pain control with TAP blocks after inguinal and ventral hernia repair, data comparing Liposomal bupivacaine (Exparel) to bupivacaine alone in formulation of the TAP block is particularly scarce. Therefore, we designed a prospective, randomized trial comparing the postoperative pain control in minimally invasive ventral and inguinal hernia repair patients who receive an Exaparel-based TAP block compared to the traditional bupivacaine (Marcaine) TAP block.
Read the detailed description
Approximately 200 patients in the study will be randomized to one of two arms: TAP block with Exparel or TAP block with bupivacaine. Randomization will be performed using a permuted block randomization algorithm (Ex. AABBABABABBABBAA, where A=Exparel group and B=Bupivacaine group). Only the participant will be blinded to the arm assignment as the knowledge of the assignment for the surgeon and anesthesiologist is needed. 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. Both of these anesthetics being evaluated and the dosage are commonly administered as standard of care (SOC). The choice of anesthetic used is up to the discretion of the surgeon in most instances. The patients will be blinded to which local anesthetic they receive. Operative technique will be standardized amongst all participating surgeons.
All patients with ventral hernias will undergo an IPOM+ technique detailed by primary closure of the defect in addition to circumferential mesh fixation with a running suture. Three or four trochars will be used ranging from 5-12mm in size. Mesh selection will be at the discretion of the surgeon with a minimum of 5cm overlap of the original defect in all directions. Defect size will be measured intraoperatively with a ruler intra-abdominally.
All patients with an inguinal hernia will undergo a transabdominal preperitoneal hernia repair with mesh placement. Three or four trochars ranging from 5-12mm will be used. Size of mesh and fixation of mesh at one or two points will be at the surgeon's discretion. The length of surgery will be recorded.
The patients will be given a packet of VAS pain assessments to take home with pre-marked time intervals to fill out at 2h, 6h, and 12h post operatively as well as every 12 hours thereafter. The patients will also be asked to record how many narcotic medications they will be consuming on a daily basis. Our team will contact patients daily to collect the data verbally which will also serve as a reminder to patients to complete this task faithfully. Each patient will follow up at one week and provide the surgeons with the packet of VAS assessments as well as bring in any excess narcotics that they did not consume. Each patient will also be told to take tylenol 500mg every 6 hours for the first 96 hours and to record whether they take any additional alternative pain medications (NSAIDs, muscle relaxants, gabapentinoids). Upon discharge, patients will be prescribed 15 pills of 5mg hydrocodone-325mg acetaminophen to be taken every 6 hours as needed for severe pain.
Data collection will include demographics of the patients including age, sex, ASA status, height/weight, BMI, preoperative pain level and previous abdominal surgeries. Intraoperative variables will include defect size, ventral vs. inguinal, number of trochar, mesh size and type, operative time. Postoperative collection will include pain scores as outlined above and narcotic use. Data analysis will include differences, if any, in post operative pain scores as well as narcotic use. This will be stratified to the inguinal hernia group vs. ventral hernias and the ventral hernia group will be stratified to size of defect and length of surgery.
- Conditions
- Inguinal Hernia, Ventral Hernia
- Being tested
- Liposomal Bupivacaine, Bupivacaine
- Medical subject headings
- Hernia, Inguinal, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal BupivacaineDrug
20cc of Liposomal Bupivacaine for TAP block
BupivacaineDrug
20cc of Bupivacaine for TAP block
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine (Exparel) | Active comparator | 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. Receives: Drug: Liposomal Bupivacaine |
| Bupivacaine (Marcaine) | Active comparator | 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. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Pain Scores using Visual Analog Scale (VAS)
Lower mean daily post-operative pain scores between participants in the Exparel vs. Bupivacaine arms recorded multiple times over the observation period. The pain scale is 0-10 with 0 being no pain to 10 being the worst pain possible.
Measured: For 1 week post-operation
Secondary outcomes (2)
Opioids Used Post-Operatively compared in anesthesia arms
The amount of opioid pills taken, as measured by morphine equivalents, is reduced depending on the type of anesthetic used during the TAP block. We will be measuring the post operative opioid usage by asking the patients how many narcotic pills they take daily after surgery for one week. Variability comes into play if we prescribe different doses of Norco or if we use Percocet, therefore we will standardize this by converting these differing dosages in to morphine equivalents for both groups.
Measured: For 1 Week post-operation
Opioids Used Post-Operatively related to Hernia Size and Surgical Time
A decrease in the total number of opioid pills taken post-operatively compared to the total surgical time and how large the hernia defect is. Increased surgical times and larger hernias may play a role in the amount of pain medication an individual may need post-operatively.
Measured: After 1 week post-operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2022
- Study start1 Mar 2022
- Primary completion31 Dec 2024
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Blind, randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leslie Son
- Sponsor type
- University, hospital or other
- Collaborators
- Our Lady of the Lake Hospital
- Responsible party
- Sponsor-investigator, Leslie Son, Our Lady of the Lake Hospital
- Investigators
- Leslie Son, PhD, Study director, Our Lady of the Lake Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177991
- Sponsor's protocol ID
- Anesthesia_Hernia_Pain
- Status last verified
- Sep 2025
- First submitted
- 2 Dec 2021
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Evaluation of Post-operative Pain Control With a TAP Block Using Exparel vs. Marcaine for Hernia Repairs
- ClinicalTrials.gov ID
- NCT05177991
- Acronym / sponsor ID
- Anesthesia_Hernia_Pain
- Conditions
- Inguinal Hernia, Ventral Hernia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Leslie SonUniversity, hospital or other
- Collaborators
- Our Lady of the Lake Hospital
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jan 2022 (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.
While studies have shown improved postoperative pain control with TAP blocks after inguinal and ventral hernia repair, data comparing Liposomal bupivacaine (Exparel) to bupivacaine alone in formulation of the TAP block is particularly scarce. Therefore, we designed a prospective, randomized trial comparing the postoperative pain control in minimally invasive ventral and inguinal hernia repair patients who receive an Exaparel-based TAP block compared to the traditional bupivacaine (Marcaine) TAP block.
Detailed description
Approximately 200 patients in the study will be randomized to one of two arms: TAP block with Exparel or TAP block with bupivacaine. Randomization will be performed using a permuted block randomization algorithm (Ex. AABBABABABBABBAA, where A=Exparel group and B=Bupivacaine group). Only the participant will be blinded to the arm assignment as the knowledge of the assignment for the surgeon and anesthesiologist is needed. 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. Both of these anesthetics being evaluated and the dosage are commonly administered as standard of care (SOC). The choice of anesthetic used is up to the discretion of the surgeon in most instances. The patients will be blinded to which local anesthetic they receive. Operative technique will be standardized amongst all participating surgeons.
All patients with ventral hernias will undergo an IPOM+ technique detailed by primary closure of the defect in addition to circumferential mesh fixation with a running suture. Three or four trochars will be used ranging from 5-12mm in size. Mesh selection will be at the discretion of the surgeon with a minimum of 5cm overlap of the original defect in all directions. Defect size will be measured intraoperatively with a ruler intra-abdominally.
All patients with an inguinal hernia will undergo a transabdominal preperitoneal hernia repair with mesh placement. Three or four trochars ranging from 5-12mm will be used. Size of mesh and fixation of mesh at one or two points will be at the surgeon's discretion. The length of surgery will be recorded.
The patients will be given a packet of VAS pain assessments to take home with pre-marked time intervals to fill out at 2h, 6h, and 12h post operatively as well as every 12 hours thereafter. The patients will also be asked to record how many narcotic medications they will be consuming on a daily basis. Our team will contact patients daily to collect the data verbally which will also serve as a reminder to patients to complete this task faithfully. Each patient will follow up at one week and provide the surgeons with the packet of VAS assessments as well as bring in any excess narcotics that they did not consume. Each patient will also be told to take tylenol 500mg every 6 hours for the first 96 hours and to record whether they take any additional alternative pain medications (NSAIDs, muscle relaxants, gabapentinoids). Upon discharge, patients will be prescribed 15 pills of 5mg hydrocodone-325mg acetaminophen to be taken every 6 hours as needed for severe pain.
Data collection will include demographics of the patients including age, sex, ASA status, height/weight, BMI, preoperative pain level and previous abdominal surgeries. Intraoperative variables will include defect size, ventral vs. inguinal, number of trochar, mesh size and type, operative time. Postoperative collection will include pain scores as outlined above and narcotic use. Data analysis will include differences, if any, in post operative pain scores as well as narcotic use. This will be stratified to the inguinal hernia group vs. ventral hernias and the ventral hernia group will be stratified to size of defect and length of surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single Blind, randomized
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine (Exparel) | Active comparator | Drug: Liposomal BupivacaineThe 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. |
| Bupivacaine (Marcaine) | Active comparator | Drug: BupivacaineThe 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18 years of age or older
- Have a ventral or inguinal hernia requiring surgical repair
Key exclusion criteria (15 listed)
- Less than 18 years of age
- Chronic pain patients
- Having a defect >10 cm in transverse dimension
- Having a defect <4 cm
- Has an allergy to bupivacaine
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 |
|---|---|---|
| Liposomal Bupivacaine20cc of Liposomal Bupivacaine for TAP block | Drug | Liposomal Bupivacaine (Exparel) |
| Bupivacaine20cc of Bupivacaine for TAP block | Drug | Bupivacaine (Marcaine) |
Primary outcome
Subjective Pain Scores using Visual Analog Scale (VAS)
Time frame: For 1 week post-operation
Lower mean daily post-operative pain scores between participants in the Exparel vs. Bupivacaine arms recorded multiple times over the observation period. The pain scale is 0-10 with 0 being no pain to 10 being the worst pain possible.
2 secondary outcomes
Opioids Used Post-Operatively compared in anesthesia arms
Time frame: For 1 Week post-operation
Opioids Used Post-Operatively related to Hernia Size and Surgical Time
Time frame: After 1 week post-operation
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 26 Sep 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Leslie Son, PhD study director
Our Lady of the Lake Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Liposomal Bupivacaine and Bupivacaine in people with Inguinal Hernia and Ventral Hernia, run by Leslie Son 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 15 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: under way, not looking for participants, as of the sponsor's last update on 26 Sep 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Subjective Pain Scores using Visual Analog Scale (VAS) (time frame: For 1 week post-operation). 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 26 Sep 2025.