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IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia

RecruitingPhase 2/3

Randomized Controlled Study Comparing the Administration of Opioids Epidurally vs IV in Patients Undergoing Laparotomy With an Epidural for Post-Operative Analgesia

Who can join

Ages 18 to 85 · All sexes

Full 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 the study

The purpose of this research study is to determine if the two common ways of administering additional opioids (morphine like substance, narcotic) with an epidural, either mixed in the epidural solution or given separately through the intravenous, are equally effective in controlling post-operative pain

What is being tested

Sponsor: University of Iowa · Participants: 80 · Started: Sep 17, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06559969

Locations in the U.S.

IowaUniversity of Iowa Health Care, Iowa City

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.