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 trial tests two methods to manage pain after major hernia surgery. One group receives pain medicine through an epidural, a small tube in the back. The other group uses various non-opioid pain medications and a numbing injection during surgery (transversus abdominis plane block). The goal is to determine which method better controls pain and reduces the need for opioid painkillers. Individuals planning hernia repair surgery who do not regularly use opioids might be suitable for this study. Researchers will monitor participants' pain levels and recovery during their hospital stay and check them again 30 days after surgery. As a Phase 4 trial, this study involves treatments already FDA-approved and proven effective, aiming to understand how they can benefit more patients.
What is the safety track record for these treatments?
Research has shown that TAP blocks are safe and effective for managing post-surgical pain. These blocks reduce the need for strong pain medications like morphine and other opioids. Importantly, no major complications have been reported from TAP blocks, and patients typically express satisfaction with the pain relief provided.
Specific safety data for thoracic epidural analgesia is not mentioned in the sources. However, its testing in a Phase 4 trial indicates that earlier trials have already found it safe and effective for similar conditions. This phase focuses on optimizing its use in a broader population rather than assessing basic safety.
Overall, both pain management methods appear well-tolerated. Participants can expect effective pain relief with minimal risk of serious side effects.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about these treatments for postoperative pain because they explore alternatives to traditional opioid-based pain management. The Epidural Analgesia approach focuses on using a thoracic epidural catheter to deliver bupivacaine and fentanyl, which may offer effective pain relief while minimizing the need for systemic opioids. On the other hand, the Opioid-Sparing Multimodal Analgesia utilizes a combination of medications like acetaminophen, ketorolac, and gabapentin, along with a transversus abdominis plane block, to control pain without relying heavily on opioids. These approaches not only aim to reduce opioid use and its side effects but also potentially provide more targeted and efficient pain management strategies.
What evidence suggests that this trial's treatments could be effective for managing postoperative pain after hernia repair surgery?
This trial will compare thoracic epidural analgesia with opioid-sparing multimodal analgesia for managing postoperative pain. Research has shown that thoracic epidural analgesia effectively reduces pain after surgery. Studies have found that combining medications like bupivacaine and fentanyl provides better pain relief than intravenous opioids like morphine. Patients often experience less pain both at rest and during movement, with fewer side effects.
In this trial, some participants will receive a transversus abdominis plane (TAP) block as part of the opioid-sparing multimodal analgesia approach. Research suggests that TAP blocks offer some pain relief after abdominal surgeries by numbing the abdominal area, reducing the need for opioid painkillers. However, the overall pain relief might not be as strong as with epidurals.678910Are 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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo open ventral hernia repair with transversus abdominis release and receive either epidural analgesia or opioid-sparing multimodal analgesia
Follow-up
Participants are monitored for recovery, side effects, and opioid consumption 30 days after surgery
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwestern University
Lead Sponsor
Citations
[Effectiveness of ropivacaine and fentanyl for postoperative ...
Conclusions: A bolus of 3 ml with continuous 4-6 ml x h(-1) epidural injection of ropivacaine plus a small dose of fentanyl would decrease postoperative pain ...
Comparative Study of 0.5% Bupivacaine, 0.5% Ropivacaine ...
Conclusion Epidural intraoperative infusion of 0.75% ropivacaine with fentanyl offers better postoperative pain relief as compared to both 0.5% bupivacaine ...
What epidural opioid results in the best analgesia outcomes ...
What epidural opioid results in the best analgesia outcomes and fewest side effects after surgery?: a meta-analysis of randomized controlled trials.
The analgesic efficacy and adverse effects of continuous ...
The study shows that, after thoracotomy, epidural sufentanil analgesia is optimal when tailored to the site of nociceptive input and combined with bupivacaine.
Analgesic effects of thoracic epidural bupivacaine and ...
Analgesic effects of thoracic epidural bupivacaine and fentanyl ... Can J Anaesth. 1994 Nov;41(11):1123. doi: 10.1007/BF03015666.
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