Recruiting
Phase 2
Phase 3

IV vs. Epidural Opioids

Sponsor:

University of Iowa

Code:

NCT06559969

Conditions

Laparotomy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Intravenous administered opioid

Epidural administered opioid

Study Details

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

Study ID

NCT06559969

Start date

Sep 17, 2024

Status verified date

Apr, 2026

Completion date

Mar 30, 2027

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

Interventions

Intravenous administered opioid

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

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

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 and Locations

Central contacts

Melinda Seering, MD

3193848411Melinda-Seering@uiowa.edu

Yair Rubin, MD

3193587989yair-rubin@uiowa.edu

Locations

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Yair Rubin, MD

319-353-7211yair-rubin@uiowa.edu

Rakesh Sondekoppam Vijayashanka, MD

rakesh-sondekoppam@uiowa.edu

Principal Investigator:

Yair Rubin, MD

More Information

Sponsor

University of Iowa

Last update posted

Apr 28, 2026

Last verified

Apr, 2026

Keywords

  • Epidural
  • PCEA
  • PCA
  • Hydromorphone
  • bupivacaine
  • analgesia
  • laparotomy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Iowa on 2026-04-28.