Status:
RECRUITING
IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia
Lead Sponsor:
University of Iowa
Conditions:
Laparotomy
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
PHASE3
Brief Summary
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 solutio...
Detailed Description
Open label, observer and patient blinded randomized control study of patients age 18 to 85 who are booked to have an open upper abdominal surgical incision where an epidural would normally be offered ...
Eligibility Criteria
Inclusion
- Age including and between 18 to 85 years old
- 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
- Patient has consented for an epidural
- Patient is able to converse in English
- Patient is able to use a patient controlled pump
Exclusion
- Has a known contraindication for an epidural
- Known mental or cognitive disability
- History of chronic opioid use or substance abuse disorder
- Pre-operative use of opioids
- History of chronic pain
- Routine use of marijuana
- Incarcerated
- Unable to converse in English
- Planned to remain intubated post-operatively
- Need for post-operative use of anticoagulant regiment that would be contraindicated with an indwelling epidural catheter
- End stage renal disease or dialysis
- Hepatic disease that affects metabolism of drugs
- Known contraindication to any of the study drugs
- Known pregnancy or positive pre-operative pregnancy test
- Known neurological condition that may affect motor or sensory systems
Key Trial Info
Start Date :
September 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06559969
Start Date
September 17 2024
End Date
May 30 2026
Last Update
July 16 2025
Active Locations (1)
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1
University of Iowa Health Care
Iowa City, Iowa, United States, 52242