Recruiting

Epidural vs. Non-opioid

Sponsor:

Northwestern University

Code:

NCT07840183

Conditions

Ventral Hernia

Ventral Hernia Repair

Postoperative Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Bupivicaine

Fentanyl

Thoracic epidural analgesia

Hydromorphone

Acetaminophen

Study Details

Brief 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. 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

Study ID

NCT07840183

Start date

Sep 18, 2026

Status verified date

Sep, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Epidural Analgesia

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.

experimental: Opioid-Sparing Multimodal Analgesia

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.

Interventions

Bupivicaine

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

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

Thoracic epidural analgesia

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

Hydromorphone

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.

Acetaminophen

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

Ketorolac

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

magnesium sulfate

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

Tramadol

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

Gabapentin

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

Cyclobenzaprine

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

transversus abdominis plane 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.

Primary outcome measure

  • Area Under the Curve (AUC) of Postoperative Pain Scores [ Time Frame: Postoperative Day 1 through Postoperative Day 4 ]

Central Contacts and Locations

Central contacts

Nancy Ly, MD

3126956868nancy.ly@nm.org

Locations

Northwestern Memorial Hospital

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Nancy Ly, MD

3126956868nancy.ly@nm.org

More Information

Sponsor

Northwestern University

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • ventral hernia
  • complex abdominal wall hernia
  • ventral hernia repair
  • postoperative pain control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by Northwestern University on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.