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NCT Number: NCT06559969

IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy 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

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Key information

Conditions

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

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Iowa Health Care

Iowa City, Iowa, 52242, United States

Location status: Recruiting

Location contact

Adeeb Oweidat, MD

SUB_INVESTIGATOR

Anil Marian, MD

SUB_INVESTIGATOR

Melinda Seering, MD

SUB_INVESTIGATOR

Nada Sadek, MD

SUB_INVESTIGATOR

Rakesh Sondekoppam Vijayashanka, MD

CONTACT

[email protected]

Rakesh Sondekoppam Vijayashanka, MD

SUB_INVESTIGATOR

Sangini Punia, MD

SUB_INVESTIGATOR

Yair Rubin, MD

CONTACT

[email protected]

319-353-7211

Yair Rubin, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

Other names: hydromorphone IV

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

Other names: Hydromorphone epidural

Primary outcomes

  1. 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

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

Secondary outcomes

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

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

    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

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

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

    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)

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

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

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Melinda Seering, MD

CONTACT

[email protected]

3193848411

Yair Rubin, MD

CONTACT

[email protected]

3193587989

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Registry information

Official study title

Randomized Controlled Study Comparing the Administration of Opioids Epidurally vs IV in Patients Undergoing Laparotomy With an Epidural for Post-Operative Analgesia

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Aug 19, 2024
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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