IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia

NCT06559969 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 202402557
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Laparotomy

Keywords

Epidural; PCEA; PCA; Hydromorphone; bupivacaine; analgesia; laparotomy

Outcome Measures

Primary Outcomes (1)

• With a local anesthetic epidural, is the epidural administration of opioids similar to opioids administered by intravenous

  Quality of Recovery (QoR) 15 score from 0-150 with the higher the score the better

  Once daily until one day after the epidural in discontinued which would mean a maximum of 8 days post-operatively

Secondary Outcomes (3)

• With a local anesthetic epidural, are there any differences in the incidence of opioid side effects between intravenous and epidural administered opioids

  Assessed daily until the epidural is removed, which is maximum of 7 days post-operatively

• Does the route of epidural opioid administration, intravenous vs epidural, affect the return of bowel function

  daily assessment until epidural removed, which is a maximum of 7 days post-operatively

• Does the route of epidural opioid administration, intravenous vs epidural, impact patient ability to be discharged

  Will follow until patient discharged or maximum 10 days post-operatively

Study Arms (2)

Control

ACTIVE COMPARATOR

Hydromorphone administered intravenous PCA combined with a continuous bupivacaine epidural infusion

Drug: Intravenous administered opioid

Treatment

ACTIVE COMPARATOR

Hydromorphone combined with bupivacaine in the epidural and administered as a continuous infusion with a PCEA bolus as necessary

Drug: Epidural administered opioid

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

Also known as: hydromorphone IV

Control

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

Also known as: Hydromorphone epidural

Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melinda Seering, MD

  Univeristy of Iowa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melinda Seering, MD

CONTACT

3193848411; Melinda-Seering@uiowa.edu

Yair Rubin, MD

CONTACT

3193587989; yair-rubin@uiowa.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient and bedside observer will be blinded to which group the patient is in
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Randomized controlled clinical trial

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 19, 2024
• Study Start: September 17, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)