IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia

University of Iowa

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Laparotomy

Treatments: Drug: Intravenous administered opioid; Drug: Epidural administered opioid

Study type: Interventional

Funder types: Other

Identifiers

NCT06559969

202402557

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

Control

Active Comparator group

Description:

Hydromorphone administered intravenous PCA combined with a continuous bupivacaine epidural infusion

Treatment:

Drug: Intravenous administered opioid

Treatment

Active Comparator group

Description:

Hydromorphone combined with bupivacaine in the epidural and administered as a continuous infusion with a PCEA bolus as necessary

Treatment:

Drug: Epidural administered opioid