A Phase 4 interventional study of Bupivicaine and Fentanyl in Ventral Hernia, Ventral Hernia Repair and Postoperative Pain, sponsored by Northwestern University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-07.
Sponsored by Northwestern University · Phase 4, Interventional, and Supportive care
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.
230 studies on the registry are indexed under Hernia, Ventral; 45 are open to participants now.
This study's planned enrollment of 40 is below the median of 90 across 153 interventional studies indexed under Hernia, Ventral.
Browse Hernia, Ventral studies →Northwestern University is the lead sponsor of 1,423 studies on the registry; 198 are open to participants now.
Of its 105 completed or terminated interventional studies of FDA-regulated products, 78 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Bupivicaine · Drug: Fentanyl · Device: Thoracic epidural analgesia · Drug: Hydromorphone
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.
Drug: Hydromorphone · Drug: Acetaminophen · Drug: Ketorolac · Drug: magnesium sulfate · Drug: Tramadol · Drug: Gabapentin · Drug: Cyclobenzaprine · Procedure: transversus abdominis plane block
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.
Opioid administered via continuous thoracic epidural infusion in combination with bupivacaine during the postoperative period, discontinued on postoperative day 3.
Catheter placed preoperatively in the thoracic epidural space to enable intraoperative and postoperative delivery of local anesthetic and opioid analgesia.
Also known as: Epidural catheter
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.
Also known as: dilaudid
Administered intraoperatively (intravenous) and on a scheduled postoperative basis as part of the opioid-sparing multimodal analgesia protocol.
Also known as: tylenol, Paracetamol
Nonsteroidal anti-inflammatory drug administered intraoperatively (intravenous) and on a scheduled postoperative basis as part of the opioid-sparing multimodal analgesia protocol.
Also known as: toradol
Administered intraoperatively (intravenous) as part of the opioid-sparing multimodal analgesia protocol.
Opioid-like analgesic administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.
Also known as: ultram
Anticonvulsant used for adjunct analgesia, administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.
Muscle relaxant administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.
Also known as: Flexeril
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.
Also known as: TAP block
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.
Time frame: Postoperative Day 1 through Postoperative Day 4
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.
Time frame: Through hospital discharge, an average of 5 days
Length of Hospital Stay
Total number of days from surgery to hospital discharge.
Time frame: Through hospital discharge, an average of 5 days
Incidence of Postoperative Ileus
Postoperative ileus, defined as the requirement for nasogastric tube decompression.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: Postoperative Day 1 through Postoperative Day 4
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Acetaminophen · Ketorolac · Magnesium Sulfate · Tramadol · Gabapentin · Cyclobenzaprine