Epidural or Opioid-Sparing? trial tests which pain plan wins after hernia surgery
NCT ID NCT07840183
First seen Sep 24, 2026 · Last updated Sep 25, 2026 · Updated 1 time
Summary
Researchers compare two ways to manage pain after open ventral hernia repair with transversus abdominis release, a major abdominal operation. One method uses a thoracic epidural catheter to deliver bupivacaine and fentanyl around the spine. The other avoids the epidural and relies on non-opioid pain medicines plus a numbing injection into the abdominal wall during surgery. Adults scheduled for this repair join the trial and are assigned by chance to one of the two methods. The team tracks pain scores and opioid use during the hospital stay and checks recovery and side effects 30 days after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- thoracic epidural analgesia with bupivacaine and fentanyl, compared with an opioid-sparing protocol of non-opioid medicines plus a numbing injection into the abdominal wall
- What this could lead to
- If the opioid-sparing approach works as well as an epidural, patients could recover from major hernia surgery with less reliance on opioids and fewer epidural-related complications.
- What could go wrong
- This is a small Phase 4 trial of 40 people at one center, so results may not apply to all patients or hospitals. Epidurals carry risks such as low blood pressure, nerve irritation, or infection, and the opioid-sparing approach may not control pain well enough for everyone.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male or female patients ≥18 years old * Symptomatic incisional ventral or parastomal hernias * Planned transversus abdominis release * Ability to provide informed consent Exclusion Criteria: * 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 * Urgent or emergent presentations * Adults unable to consent * Pregnant patients
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Northwestern Memorial Hospital
RECRUITINGChicago, Illinois, 60611, United States
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- Non-Opioid pain drug tested for hysterectomy recovery
- Which additive keeps hernia pain away longer?