๐ฌIn plain words
What the trial is, and whether it could suit you
This is a prospective randomized open-label noninferiority trial that compares intrathecal morphine injection and continuous wound infiltration after open pancreaticoduodenectomy.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Adults 19 years of age or older
* Scheduled for elective open pancreaticoduodenectomy or pylorus preseriving pancreaticoduodenectomy
* Disease of periampullary lesions
* Perfromance status assessed with ECOG score is 0 or 1 at the time of enrollment
* Able to provide written informed consent to participate in the study, understand the procedures of this study, and complete patient-reported questionnaires
* American Society of Anesthesiologists physical status I to III
Exclusion Criteria:
* Hypersensitivity to medications used for pain control (fentanyl, ropivacaine, morphine, acetaminophen, NSAIDs)
* Cognitive impairment that affects using patient-controlled analgesia device or answering patient-reported questionnaires
* Infection or anatomical abnormalities of the abdominal wall and skin that preclude catheterization for continuous wound infiltration
* Contraindicated for intrathecal injection due to any coagulation disorder or continued use of anticoagulants
* Have a major medical or psychiatric illness that would affect response to treatment
* History of chronic pain, or chronic use of analgesics or psychiatric medications
* Have severe liver or kidney disease
* Anyone who are not appropriate for the study in the opinion of the investigators
๐
What it tests
- Intrathecal morphine injection
- Continuous wound infiltration
Seoul National University Hospital
Seoul, South Korea
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.