IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT06559969
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Laparotomy

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Intravenous administered opioid — DRUG
    Hydromorphone will be received intravenously using a patient controlled administration pump, as well as patient will have a continuous bupivacaine epidural infusion
  • Epidural administered opioid — DRUG
    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

Study Details

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

Key Dates

Start date
Sep 17, 2024
Status verified
Apr 2026
Primary completion
Dec 30, 2026
Completion
Mar 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Active Comparator: Control
    Hydromorphone administered intravenous PCA combined with a continuous bupivacaine epidural infusion
  • Active Comparator: Treatment
    Hydromorphone combined with bupivacaine in the epidural and administered as a continuous infusion with a PCEA bolus as necessary

Primary Outcome Measure

With a local anesthetic epidural, is the epidural administration of opioids similar to opioids administered by intravenous [ Time Frame: Once daily until one day after the epidural in discontinued which would mean a maximum of 8 days post-operatively ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Health CareIowa CityIowa52242
Yair Rubin, MD
[email protected]
319-353-7211
Rakesh Sondekoppam Vijayashanka, MD
[email protected]
Yair Rubin, MD (PRINCIPAL_INVESTIGATOR)
Rakesh Sondekoppam Vijayashanka, MD (SUB_INVESTIGATOR)
Melinda Seering, MD (SUB_INVESTIGATOR)
Adeeb Oweidat, MD (SUB_INVESTIGATOR)
Anil Marian, MD (SUB_INVESTIGATOR)
Sangini Punia, MD (SUB_INVESTIGATOR)
Nada Sadek, MD (SUB_INVESTIGATOR)

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By research site
University of Iowa Health Care· Iowa City, IA

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