IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intravenous administered opioid, Epidural administered opioid.
- Who it may be relevant to
- Registry conditions: Laparotomy. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Randomized Controlled Study Comparing the Administration of Opioids Epidurally vs IV in Patients Undergoing Laparotomy With an Epidural for Post-Operative Analgesia
Overview
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.
Interventions
- 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 - 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
Primary outcome measures
- 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]
Secondary outcome measures (3)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Iowa Health Care — Iowa City
Identifiers
NCT: NCT06559969 · 202402557