IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia

NCT ID: NCT06559969

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-17
• Study Completion Date: 2026-05-30

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

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.

Conditions

Laparotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control

Hydromorphone administered intravenous PCA combined with a continuous bupivacaine epidural infusion

Group Type: ACTIVE_COMPARATOR

Intravenous administered opioid

Intervention Type: DRUG

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

Treatment

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

Group Type: ACTIVE_COMPARATOR

Epidural administered opioid

Intervention Type: 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

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

Intervention Type: 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

Intervention Type: DRUG

Other Intervention Names

hydromorphone IV; Hydromorphone epidural

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Iowa

OTHER

Sponsor Role: lead

Responsible Party

Melinda Seering

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melinda Seering, MD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Iowa

Locations

University of Iowa Health Care

Iowa City, Iowa, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Melinda Seering, MD

Role: CONTACT

Melinda-Seering@uiowa.edu

3193848411

Yair Rubin, MD

Role: CONTACT

yair-rubin@uiowa.edu

3193587989

Facility Contacts

Yair Rubin, MD

Role: primary

yair-rubin@uiowa.edu

319-353-7211

Rakesh Sondekoppam Vijayashanka, MD

Role: backup

rakesh-sondekoppam@uiowa.edu

Other Identifiers

202402557

Identifier Type: -

Identifier Source: org_study_id