Epidural vs Opioid-Sparing Analgesia for Postoperative Pain
(EASE-TAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults having open ventral hernia repair surgery with transversus abdominis release. People who are not eligible include those with certain medical conditions or allergies that would make either pain control method unsafe, but specific criteria aren't listed here.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Thoracic epidural analgesia
- transversus abdominis plane block
Trial Overview
The study compares two ways to manage pain after major hernia surgery: one group gets an epidural (pain medicine delivered near the spine), and the other receives a mix of non-opioid medicines plus a numbing injection in the abdomen. Patients are randomly assigned to each group.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
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Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
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