Clinical trial NCT06559969: IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia
Official title: Randomized Controlled Study Comparing the Administration of Opioids Epidurally vs IV in Patients Undergoing Laparotomy With an Epidural for Post-Operative Analgesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
PHASE3
Conditions: Laparotomy
Keywords: Epidural
PCEA
PCA
Hydromorphone
bupivacaine
analgesia
laparotomy
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled clinical trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

1. Age including and between 18 to 85 years old
2. 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
3. Patient has consented for an epidural
4. Patient is able to converse in English
5. Patient is able to use a patient controlled pump

Exclusion Criteria:

1. Has a known contraindication for an epidural
2. Known mental or cognitive disability
3. History of chronic opioid use or substance abuse disorder
4. Pre-operative use of opioids
5. History of chronic pain
6. Routine use of marijuana
7. Incarcerated
8. Unable to converse in English
9. Planned to remain intubated post-operatively
10. Need for post-operative use of anticoagulant regiment that would be contraindicated with an indwelling epidural catheter
11. End stage renal disease or dialysis
12. Hepatic disease that affects metabolism of drugs
13. Known contraindication to any of the study drugs
14. Known pregnancy or positive pre-operative pregnancy test
15. Known neurological condition that may affect motor or sensory systems

Primary outcomes:
measure: With a local anesthetic epidural, is the epidural administration of opioids similar to opioids administered by intravenous
timeFrame: Once daily until one day after the epidural in discontinued which would mean a maximum of 8 days post-operatively
Secondary outcomes:
measure: With a local anesthetic epidural, are there any differences in the incidence of opioid side effects between intravenous and epidural administered opioids
timeFrame: Assessed daily until the epidural is removed, which is maximum of 7 days post-operatively
measure: Does the route of epidural opioid administration, intravenous vs epidural, affect the return of bowel function
timeFrame: daily assessment until epidural removed, which is a maximum of 7 days post-operatively
measure: Does the route of epidural opioid administration, intravenous vs epidural, impact patient ability to be discharged
timeFrame: Will follow until patient discharged or maximum 10 days post-operatively
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Health Care
state: Iowa
Study officials:
affiliation: Univeristy of Iowa
name: Melinda Seering, MD
role: PRINCIPAL_INVESTIGATOR
References: