LaparotomyPhase 2/3NCT06559969
IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia
A Phase 2/3 study testing Intravenous administered opioid and Epidural administered opioid in people with Laparotomy, run by University of Iowa at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Laparotomy
- What is being tested?
- Intravenous administered opioid and Epidural administered opioid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Sep 2024to 30 Mar 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
Yair Rubin, MD, 319-353-7211, yair-rubin@uiowa.edu
Rakesh Sondekoppam Vijayashanka, MD, rakesh-sondekoppam@uiowa.edu
About this study
Official title: 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
Read the 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
- Being tested
- Intravenous administered opioid, Epidural administered opioid
- Keywords
- Epidural, PCEA, PCA, Hydromorphone, bupivacaine, analgesia, laparotomy
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous administered opioidDrug
Also called hydromorphone IV
Hydromorphone will be received intravenously using a patient controlled administration pump, as well as patient will have a continuous bupivacaine epidural infusion
Epidural administered opioidDrug
Also called Hydromorphone epidural
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
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Hydromorphone administered intravenous PCA combined with a continuous bupivacaine epidural infusion Receives: 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 Receives: Drug: Epidural administered opioid |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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)
Measured: 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)
Measured: Will follow until patient discharged or maximum 10 days post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start17 Sep 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparotomyStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled clinical trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melinda Seering, University of Iowa
- Investigators
- Melinda Seering, MD, Principal investigator, Univeristy of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559969
- Sponsor's protocol ID
- 202402557
- Status last verified
- Apr 2026
- First submitted
- 24 Jul 2024
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study Comparing the Administration of Opioids Epidurally vs IV in Patients Undergoing Laparotomy With an Epidural for Post-Operative Analgesia
- ClinicalTrials.gov ID
- NCT06559969
- Acronym / sponsor ID
- 202402557
- Conditions
- Laparotomy
- Keywords
- Epidural, PCEA, PCA, Hydromorphone, bupivacaine, analgesia, laparotomy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Intravenous administered opioidHydromorphone administered intravenous PCA combined with a continuous bupivacaine epidural infusion |
| Treatment | Active comparator | Drug: Epidural administered opioidHydromorphone combined with bupivacaine in the epidural and administered as a continuous infusion with a PCEA bolus as necessary |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous administered opioidAlso: hydromorphone IVHydromorphone will be received intravenously using a patient controlled administration pump, as well as patient will have a continuous bupivacaine epidural infusion | Drug | Control |
| Epidural administered opioidAlso: Hydromorphone epiduralHydromorphone 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 | Drug | Treatment |
Primary outcome
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
3 secondary outcomes
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
Related trials for Laparotomy
Recruiting
Implementation of a Pain Management Plan in Major Open Abdominal Surgeries.
Abdomen Cancer, Pancreas Adenocarcinoma (MSI-H)
Enrolling by invitationObservational study
Intestinal Obstruction Surgery. Acute Abdominal Pathology. №9:05/05/2026
Small Bowel Adhesion, Obstruction Bowel
Active, not recruitingPhase 4
Early vs Postponed Parenteral Nutrition After Emergency Abdominal Surgery
Laparotomy, Bowel Obstruction
Active, not recruiting
Prophylactic Reinforcement of Ventral Abdominal Incisions Trial
Open Midline Laparotomy
Not yet recruitingObservational study
Surgical Apgar Score for Identifying Patients Who May Need Intensive Care After Emergency Abdominal Surgery
Emergency General Surgery Laparotomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melinda Seering, MD principal investigator
Univeristy of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intravenous administered opioid and Epidural administered opioid in people with Laparotomy, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melinda Seering, MD (3193848411, Melinda-Seering@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.