RecruitingPhase 2Phase 3NCT06559969

IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia

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

Sponsor

University of Iowa

Enrollment

80 participants

Start Date

Sep 17, 2024

Study Type

INTERVENTIONAL

Conditions

Laparotomy

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 solution or given separately through the intravenous, are equally effective in controlling post-operative pain

Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

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 Criteria15

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

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Interventions

DRUGIntravenous administered opioid

Hydromorphone will be received intravenously using a patient controlled administration pump, as well as patient will have a continuous bupivacaine epidural infusion

DRUGEpidural administered opioid

Hydromorphone will be added to the bupivacaine in the epidural and will have a continuous infusion along with the ability for the patient to receive epidural boluses of the medications by a patient controlled epidural administration pump