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Search / Trial NCT06559969

IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia

Launched by UNIVERSITY OF IOWA · Aug 14, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Epidural Pcea Pca Hydromorphone Bupivacaine Analgesia Laparotomy

ClinConnect Summary

This clinical trial is exploring two different methods of giving pain relief after a major surgery called laparotomy, which involves making a large incision in the abdomen. The researchers want to find out if using opioids (a type of strong pain medicine) through an epidural (a method of delivering medicine into the lower back) is just as effective when mixed with local anesthetics versus when given through an IV (intravenously). The goal is to help patients manage their pain after surgery more effectively.

To join this study, participants need to be between 18 and 85 years old and scheduled for an open abdominal surgery where an epidural is usually offered. They must also be able to communicate in English and use a special pump to control their own pain medication. However, individuals with certain conditions, such as a history of substance abuse or specific medical issues, will not be eligible. Participants in the trial will receive either method of pain relief and will be monitored to see how well it works for managing their post-operative pain. This study is currently recruiting participants, so there is an opportunity to take part in important research that could improve pain management options after surgery.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Age including and between 18 to 85 years old
  • 2. Planned open abdominal procedure with an incision that is or includes above the umbilicus, where epidural would normally be offered and epidural would be maintained for an average of 4 to 5 days
  • 3. Patient has consented for an epidural
  • 4. Patient is able to converse in English
  • 5. Patient is able to use a patient controlled pump
  • Exclusion Criteria:
  • 1. Has a known contraindication for an epidural
  • 2. Known mental or cognitive disability
  • 3. History of chronic opioid use or substance abuse disorder
  • 4. Pre-operative use of opioids
  • 5. History of chronic pain
  • 6. Routine use of marijuana
  • 7. Incarcerated
  • 8. Unable to converse in English
  • 9. Planned to remain intubated post-operatively
  • 10. Need for post-operative use of anticoagulant regiment that would be contraindicated with an indwelling epidural catheter
  • 11. End stage renal disease or dialysis
  • 12. Hepatic disease that affects metabolism of drugs
  • 13. Known contraindication to any of the study drugs
  • 14. Known pregnancy or positive pre-operative pregnancy test
  • 15. Known neurological condition that may affect motor or sensory systems

About University Of Iowa

The University of Iowa, a leading academic and research institution, is dedicated to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university harnesses the expertise of its faculty and researchers to investigate cutting-edge therapies and treatments across various medical fields. Committed to ethical research practices and patient-centered care, the University of Iowa strives to contribute significantly to medical knowledge and improve health outcomes through rigorous scientific inquiry and community engagement.

Locations

Iowa City, Iowa, United States

Patients applied

0 patients applied

Trial Officials

Melinda Seering, MD

Principal Investigator

Univeristy of Iowa

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported