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

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

Study Overview

• Status: Recruiting
• Conditions: Laparotomy
• Intervention / Treatment: Drug: Intravenous administered opioid; Drug: Epidural administered opioid

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 and expected to be used for an average of 4 to 5 days.

Study will be done at University of Iowa Hospitals and Clinics main operating room and post-operative surgical wards.

Eligible patients who choose to consent to participate in the study will be randomized to either have the opioid administered intravenously using patient controlled administration (PCA) device along with a local anesthetic only continuous epidural infusion ,the control group, or to the treatment group of the opioid combined with the local anesthetic in the epidural with a continuous infusion combined with patient controlled epidural administered (PCEA) bolus. The epidural pump along with the PCA machine will be placed in such away that they can be obscured by a removable cover. The patient will be seen daily to obtain pain and satisfaction scores using the Quality of Recovery (QoR) 15. Secondary data will also be collected including presence of side effects, ability to mobilize, signs of return of bowel function, need for supplemental oxygen and total amount of opioid required. Patients will be assigned a study number, which all data will be kept under.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Melinda Seering, MD; Phone Number: 3193848411; Email: Melinda-Seering@uiowa.edu
• Study Contact Backup: Name: Yair Rubin, MD; Phone Number: 3193587989; Email: yair-rubin@uiowa.edu

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Recruiting
      • University of Iowa Health Care
      • Contact: Yair Rubin, MD; Phone Number: 319-353-7211; Email: yair-rubin@uiowa.edu
      • Contact: Rakesh Sondekoppam Vijayashanka, MD; Email: rakesh-sondekoppam@uiowa.edu
      • Principal Investigator: Yair Rubin, MD
      • Sub-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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; Hydromorphone administered intravenous PCA combined with a continuous bupivacaine epidural infusion	Drug: 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; Other Names: hydromorphone IV
Active Comparator: Treatment; Hydromorphone combined with bupivacaine in the epidural and administered as a continuous infusion with a PCEA bolus as necessary	Drug: 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; Other Names: Hydromorphone epidural

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
With a local anesthetic epidural, are there any differences in the incidence of opioid side effects between intravenous and epidural administered opioids	will assess patient for symptoms suggestive of opioid side effects and look in the patient's chart to see if they require any medication treatments that could be linked to opioid side effects	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	Will assess patient and chart looking for signs of bowel function return and look how patient is able to progress with diet (time in days until signs of bowel function return)	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 look in chart to see when surgery documents that they feel patient has recovered enough to be discharged home (time in days until dischargeable)	Will follow until patient discharged or maximum 10 days post-operatively

Collaborators and Investigators

• Sponsor: University of Iowa
• Investigators: Principal Investigator: Melinda Seering, MD, Univeristy of Iowa

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): March 30, 2027

Study Registration Dates

• First Submitted: July 24, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: PCA; laparotomy; Epidural; analgesia; bupivacaine; Hydromorphone; PCEA
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Agnosia; Physiological Effects of Drugs; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics; Narcotics; Analgesics, Opioid; Hydromorphone
• Other Study ID Numbers: 202402557

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No