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

Conditions

• Postoperative Pain
• Ventral Hernia
• Ventral Hernia Repair

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed

Sep 24, 2026

Start date

Sep 25, 2026

Status verified

Oct 2026

Primary completion

Sep 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

40 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

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.

Primary Outcome Measure

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

Central Contacts

• Nancy Ly, MD
  3126956868
  [email protected]

Locations (1)

Find similar trials in Chicago, IL

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