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IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia

ConditionLaparotomy
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Iowa

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intravenous administered opioid

    Drug

    Hydromorphone will be received intravenously using a patient controlled administration pump, as well as patient will have a continuous bupivacaine epidural infusion

  • Epidural administered opioid

    Drug

    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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: ControlActive comparator 1 intervention
Group B: TreatmentActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

With a local anesthetic epidural, is the epidural administration of opioids similar to opioids administered by intravenous

Quality of Recovery (QoR) 15 score from 0-150 with the higher the score the better

Time frame
Once daily until one day after the epidural in discontinued which would mean a maximum of 8 days post-operatively

Secondary outcomes

1

With a local anesthetic epidural, are there any differences in the incidence of opioid side effects between intravenous and epidural administered opioids

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
Assessed daily until the epidural is removed, which is maximum of 7 days post-operatively
2

Does the route of epidural opioid administration, intravenous vs epidural, affect the return of bowel function

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
daily assessment until epidural removed, which is a maximum of 7 days post-operatively
3

Does the route of epidural opioid administration, intravenous vs epidural, impact patient ability to be discharged

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)

Time frame
Will follow until patient discharged or maximum 10 days post-operatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Iowa

Lead sponsor

Source ClinicalTrials.gov
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