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NCT Number: NCT07840183

Epidural Analgesia Versus Opioid-sparing Analgesia for Open Ventral Hernia Repair With Transversus Abdominis Release

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.

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Key information

Conditions

Ventral Hernia Hernia Hernia, Abdominal Hernia, Ventral Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms Ventral Hernia Repair

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bupivicaine

Drug

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.

Fentanyl

Drug

Opioid administered via continuous thoracic epidural infusion in combination with bupivacaine during the postoperative period, discontinued on postoperative day 3.

Thoracic epidural analgesia

Device

Catheter placed preoperatively in the thoracic epidural space to enable intraoperative and postoperative delivery of local anesthetic and opioid analgesia.

Other names: Epidural catheter

Hydromorphone

Drug

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.

Other names: dilaudid

Acetaminophen

Drug

Administered intraoperatively (intravenous) and on a scheduled postoperative basis as part of the opioid-sparing multimodal analgesia protocol.

Other names: tylenol, Paracetamol

Ketorolac

Drug

Nonsteroidal anti-inflammatory drug administered intraoperatively (intravenous) and on a scheduled postoperative basis as part of the opioid-sparing multimodal analgesia protocol.

Other names: toradol

Magnesium sulfate

Drug

Administered intraoperatively (intravenous) as part of the opioid-sparing multimodal analgesia protocol.

Tramadol

Drug

Opioid-like analgesic administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.

Other names: ultram

Gabapentin

Drug

Anticonvulsant used for adjunct analgesia, administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.

Cyclobenzaprine

Drug

Muscle relaxant administered on a scheduled postoperative basis (oral) as part of the opioid-sparing multimodal analgesia protocol.

Other names: Flexeril

transversus abdominis plane block

Procedure

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.

Other names: TAP block

Primary outcomes

  1. Area Under the Curve (AUC) of Postoperative Pain Scores

    Time frame: Postoperative Day 1 through Postoperative Day 4

    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.

Secondary outcomes

  1. Total Postoperative Opioid Consumption

    Time frame: Through hospital discharge, an average of 5 days

    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.

  2. Length of Hospital Stay

    Time frame: Through hospital discharge, an average of 5 days

    Total number of days from surgery to hospital discharge.

  3. Incidence of Postoperative Ileus

    Time frame: Through hospital discharge, an average of 5 days

    Postoperative ileus, defined as the requirement for nasogastric tube decompression.

  4. Incidence of Epidural-Related Complications

    Time frame: Through hospital discharge, an average of 5 days

    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.

  5. Patient Satisfaction with Pain Management (Binary)

    Time frame: At hospital discharge

    Patient satisfaction with postoperative pain management, assessed prior to discharge using a binary (yes/no) question.

  6. 30-Day Postoperative Complications

    Time frame: 30 days (± 15 days) postoperatively

    Incidence of wound complications, respiratory complications, hospital readmission, reoperation, and hernia recurrence, assessed as part of standard of care data collection.

  7. 30-Day Postoperative Opioid Prescribing and Consumption

    Time frame: 30 days (± 15 days) postoperatively

    Number and dose of opioids prescribed, and total opioids consumed, in the 30 days following surgery

  8. Patient Satisfaction with Pain Management (Numeric Scale)

    Time frame: At hospital discharge

    Patient satisfaction with postoperative pain management, assessed prior to discharge using a 1-10 numeric satisfaction scale, with higher scores indicating greater satisfaction.

  9. Daily Average Numeric Rating Scale Pain Score

    Time frame: Postoperative Day 1 through Postoperative Day 4

    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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Epidural Analgesia verSus Opioid-sparing analgEsia Protocol for Pain Control Following Open Ventral Hernia Repair With Transversus Abdominis Release: A Randomized Controlled Trial

Acronym: EASE-TAR

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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