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RECRUITING
NCT07840183
PHASE4

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

Sponsor: Northwestern University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2026-09-18

Completion Date

2027-11

Last Updated

2026-09-24

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

Fentanyl

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

DEVICE

Thoracic epidural analgesia

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

DRUG

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.

DRUG

Acetaminophen

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

DRUG

Ketorolac

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

DRUG

magnesium sulfate

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

DRUG

Tramadol

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

DRUG

Gabapentin

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

DRUG

Cyclobenzaprine

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

PROCEDURE

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.

Locations (1)

Northwestern Memorial Hospital

Chicago, Illinois, United States