Ventral HerniaPhase 4EASE-TARNCT07840183
Epidural Analgesia Versus Opioid-sparing Analgesia for Open Ventral Hernia Repair With Transversus Abdominis Release
A Phase 4 study testing Bupivicaine, Fentanyl and Thoracic epidural analgesia in people with Ventral Hernia and Ventral Hernia Repair, run by Northwestern University at 1 site in United States.
Trial summary
This study is comparing two ways to manage pain after a major hernia repair surgery called "transversus abdominis release." One method uses an epidural, a small tube placed in the back that delivers pain medicine directly around the spine. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ventral Hernia, Ventral Hernia Repair, Postoperative Pain
- What is being tested?
- Bupivicaine, Fentanyl and Thoracic epidural analgesia
- Type of treatment
- Pill or oral medicine, Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2026to Nov 2027
- Phase
- Phase 4
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥18 years old
- Symptomatic incisional ventral or parastomal hernias
- Planned transversus abdominis release
- Ability to provide informed consent
Who cannot join
- Contraindications to epidural placement
- Chronic pre-operative opioid use, defined as daily opioid use for 30-days prior to surgery
- Allergy or intolerance to study medications
- Age greater than 80 years
- Impaired renal function - defined as creatinine clearance or estimated GFR of <60ml/min
- Planned ICU admissions with post-operative intubation
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- Urgent or emergent presentations
- Adults unable to consent
- Pregnant patients
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, 1 recruiting
- Recruiting
Northwestern Memorial Hospital
Chicago, Illinois, 60611
Nancy Ly, MD, 3126956868, nancy.ly@nm.org
About this study
Official title: Epidural Analgesia verSus Opioid-sparing analgEsia Protocol for Pain Control Following Open Ventral Hernia Repair With Transversus Abdominis Release: A Randomized Controlled Trial
This study is comparing two ways to manage pain after a major hernia repair surgery called "transversus abdominis release." One method uses an epidural, a small tube placed in the back that delivers pain medicine directly around the spine. The other method avoids the epidural and instead uses a combination of non-opioid pain medicines, along with an injection of numbing medicine into the abdominal wall during surgery. Patients who still have pain that is hard to control with either method will be given rescue pain medicine through an intravenous (IV) pump.
Researchers want to learn which method controls pain better and results in patients using fewer opioid pain medicines after surgery. Participants will be randomly assigned (like a coin flip) to one of the two pain control methods. Pain levels and medication use will be tracked during the hospital stay, and participants will be contacted 30 days after surgery to check on recovery and any side effects.
- Conditions
- Ventral Hernia, Ventral Hernia Repair, Postoperative Pain
- Being tested
- Bupivicaine, Fentanyl, Thoracic epidural analgesia, Hydromorphone, Acetaminophen
- Keywords
- ventral hernia, complex abdominal wall hernia, ventral hernia repair, postoperative pain control
- Medical subject headings
- Hernia, Ventral, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivicaineDrug
Local anesthetic administered via thoracic epidural catheter, both as an intraoperative bolus and as part of a standardized postoperative continuous infusion combined with fentanyl, discontinued on postoperative day 3.
FentanylDrug
Opioid administered via continuous thoracic epidural infusion in combination with bupivacaine during the postoperative period, discontinued on postoperative day 3.
Thoracic epidural analgesiaDevice
Also called Epidural catheter
Catheter placed preoperatively in the thoracic epidural space to enable intraoperative and postoperative delivery of local anesthetic and opioid analgesia.
HydromorphoneDrug
Also called dilaudid
Opioid administered intravenously via patient-controlled analgesia (PCA) as rescue therapy for participants in either study arm who have inadequate pain control with their assigned analgesia protocol.
AcetaminophenDrug
Also called tylenol, Paracetamol
Administered intraoperatively (intravenous) and on a scheduled postoperative basis as part of the opioid-sparing multimodal analgesia protocol.
KetorolacDrug
Also called toradol
Nonsteroidal anti-inflammatory drug administered intraoperatively (intravenous) and on a scheduled postoperative basis as part of the opioid-sparing multimodal analgesia protocol.
magnesium sulfateDrug
Administered intraoperatively (intravenous) as part of the opioid-sparing multimodal analgesia protocol.
TramadolDrug
Also called ultram
Opioid-like analgesic administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.
GabapentinDrug
Anticonvulsant used for adjunct analgesia, administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.
CyclobenzaprineDrug
Also called Flexeril
Muscle relaxant administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.
transversus abdominis plane blockProcedure or surgery
Also called TAP block
Regional anesthetic technique performed intraoperatively by the surgeon, injecting local anesthetic into the transversus abdominis plane of the abdominal wall, as part of the opioid-sparing multimodal analgesia protocol.
| Study group | Role | What they receive |
|---|---|---|
| Epidural Analgesia | Active comparator | Patients will receive a preoperative thoracic epidural catheter with intraoperative bupivacaine dosing and a standardized postoperative bupivacaine/fentanyl infusion, discontinued on postoperative day 3. Patients will not receive IV acetaminophen or IV ketorolac but will receive other standard multimodal agents. Patients requiring rescue analgesia will be transitioned to bupivacaine-only epidural dosing and IV hydromorphone PCA as needed. Receives: Drug: Bupivicaine; Drug: Fentanyl; Device: Thoracic epidural analgesia; Drug: Hydromorphone |
| Opioid-Sparing Multimodal Analgesia | Experimental | Patients will receive intraoperative IV acetaminophen, ketorolac, magnesium sulfate, and a surgeon-administered transversus abdominis plane block, followed by scheduled postoperative multimodal analgesia (acetaminophen, ketorolac, tramadol, gabapentin, cyclobenzaprine) and an ice pack. IV hydromorphone will be used only as rescue therapy for inadequate pain control. Receives: Drug: Hydromorphone; Drug: Acetaminophen; Drug: Ketorolac; Drug: magnesium sulfate; Drug: Tramadol; Drug: Gabapentin; Drug: Cyclobenzaprine; Procedure: transversus abdominis plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Curve (AUC) of Postoperative Pain Scores
Postoperative pain will be measured using the Numeric Rating Scale (NRS, 0-10) at standardized 6-hour intervals over the first four postoperative days. The area under the curve of these serial measurements will be calculated to reflect cumulative postoperative pain burden.
Measured: Postoperative Day 1 through Postoperative Day 4
Secondary outcomes (9)
Total Postoperative Opioid Consumption
Total opioid consumption during hospitalization, measured in oral morphine milligram equivalents (MME). For patients receiving epidural analgesia, neuraxial opioid use will be quantified and reported separately from oral/intravenous MME.
Measured: Through hospital discharge, an average of 5 days
Length of Hospital Stay
Total number of days from surgery to hospital discharge.
Measured: Through hospital discharge, an average of 5 days
Incidence of Postoperative Ileus
Postoperative ileus, defined as the requirement for nasogastric tube decompression.
Measured: Through hospital discharge, an average of 5 days
Incidence of Epidural-Related Complications
Hypotension (defined as a drop in systolic blood pressure or mean arterial pressure of more than 20% from baseline) and urinary retention requiring Foley catheter reinsertion.
Measured: Through hospital discharge, an average of 5 days
Patient Satisfaction with Pain Management (Binary)
Patient satisfaction with postoperative pain management, assessed prior to discharge using a binary (yes/no) question.
Measured: At hospital discharge
30-Day Postoperative Complications
Incidence of wound complications, respiratory complications, hospital readmission, reoperation, and hernia recurrence, assessed as part of standard of care data collection.
Measured: 30 days (± 15 days) postoperatively
30-Day Postoperative Opioid Prescribing and Consumption
Number and dose of opioids prescribed, and total opioids consumed, in the 30 days following surgery
Measured: 30 days (± 15 days) postoperatively
Patient Satisfaction with Pain Management (Numeric Scale)
Patient satisfaction with postoperative pain management, assessed prior to discharge using a 1-10 numeric satisfaction scale, with higher scores indicating greater satisfaction.
Measured: At hospital discharge
Daily Average Numeric Rating Scale Pain Score
Average Numeric Rating Scale (NRS) pain score calculated for each of the first four postoperative days, on a scale of 1-10, with 0 meaning no pain and 10 being the worst pain imaginable
Measured: Postoperative Day 1 through Postoperative Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start25 Sep 2026
- Primary completionSep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Megan Melland-Smith, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07840183
- Sponsor's protocol ID
- STU00225786
- Acronym
- EASE-TAR
- Status last verified
- Oct 2026
- First submitted
- 10 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Morrell DJ, Doble JA, Hendriksen BS, Horne CM, Hollenbeak CS, Pauli EM. Comparative effectiveness of surgeon-performed transversus abdominis plane blocks and epidural catheters following open hernia repair with transversus abdominis release. Hernia. 2021 Dec;25(6):1611-1620. doi: 10.1007/s10029-021-02454-0. Epub 2021 Jul 28.
PubMed 34319465Melland-Smith M, Zheng X, Messer N, Beffa L, Petro C, Prabhu A, Krpata D, Rosen M, Miller B. Epidural analgesia and post-operative ileus after incisional hernia repair with transversus abdominis release: Results of a 5-year quality improvement initiative. Am J Surg. 2024 Apr;230:30-34. doi: 10.1016/j.amjsurg.2023.11.009. Epub 2023 Nov 11.
PubMed 38000938