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Compares treatment options for Laparotomy
Official title IV vs Epidural Opioids + Epidural Local Anesthetic for Laparotomy Analgesia
ClinicalTrials.gov ID: NCT06559969
What this study is testing
What is Intravenous administered opioid?
Intravenous administered opioid is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for laparotomy.
Also referred to as hydromorphone IV.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- 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...
- Patient has consented for an epidural
- Patient is able to converse in English
- Patient is able to use a patient controlled pump
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.