University of Iowa Health Care
Iowa City, Iowa, 52242, United States
Location status: Recruiting
NCT Number: NCT06559969
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
Interested in participating?
Request Info18 year–85 year
All sexes
Interventional
Phase 2 / Phase 3
Iowa City, Iowa, 52242, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
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
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)
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)
Interested in participating?
Request InfoUniversity of Iowa
Other
Randomized Controlled Study Comparing the Administration of Opioids Epidurally vs IV in Patients Undergoing Laparotomy With an Epidural for Post-Operative Analgesia
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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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