Intrathecal Morphine Injection Versus Continuous Wound Infiltration After Pancreaticoduodenectomy (NCT06761989) | Clinical Trial Compass
RecruitingNot Applicable
Intrathecal Morphine Injection Versus Continuous Wound Infiltration After Pancreaticoduodenectomy
South Korea104 participantsStarted 2025-01-15
Plain-language summary
This is a prospective randomized open-label noninferiority trial that compares intrathecal morphine injection and continuous wound infiltration after open pancreaticoduodenectomy.
Who can participate
Age range19 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Mean pain intensity on cough assessed by K-DVRPS at 24, 48, and 72 hours from the end of anesthesia