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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Hydromorphone administered intravenous PCA combined with a continuous bupivacaine epidural infusion |
|
| Treatment | Active Comparator | Hydromorphone combined with bupivacaine in the epidural and administered as a continuous infusion with a PCEA bolus as necessary |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Melinda Seering, MD | Contact | 3193848411 | Melinda-Seering@uiowa.edu | |
| Yair Rubin, MD | Contact | 3193587989 | yair-rubin@uiowa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Melinda Seering, MD | Univeristy of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Health Care | Recruiting | Iowa City | Iowa | 52242 | United States |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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Randomized controlled clinical trial
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Patient and bedside observer will be blinded to which group the patient is in
|
| 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 |
|
|
| 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 |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |