IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia

Phase 2

Recruiting

Interventions: Drug: Epidural administered opioid
Drug: Intravenous administered opioid

Brief 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

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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Treatment	Epidural administered opioid	Hydromorphone combined with bupivacaine in the epidural and administered as a continuous infusion with a PCEA bolus as necessary
Control	Intravenous administered opioid	Hydromorphone administered intravenous PCA combined with a continuous bupivacaine epidural infusion

Primary Outcome Measures

Name	Time	Method
With a local anesthetic epidural, is the epidural administration of opioids similar to opioids administered by intravenous	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 Outcome Measures

Name	Time	Method
With a local anesthetic epidural, are there any differences in the incidence of opioid side effects between intravenous and epidural administered opioids	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
Does the route of epidural opioid administration, intravenous vs epidural, affect the return of bowel function	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)
Does the route of epidural opioid administration, intravenous vs epidural, impact patient ability to be discharged	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)

Locations (1): University of Iowa Health Care
🇺🇸
Iowa City, Iowa, United States