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Compares treatment options for Pain Management
Official title Intrathecal Morphine Injection Versus Continuous Wound Infiltration After Pancreaticoduodenectomy
ClinicalTrials.gov ID: NCT06761989
What this study is testing
What is Intrathecal morphine injection?
Intrathecal morphine injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pain management.
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
- This is a prospective randomized open-label noninferiority trial that compares intrathecal morphine injection and continuous wound infiltration after open pancreaticoduodenectomy.
- 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 19 and older
You may be able to join if
- 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...
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, Seoul, South Korea
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, 19 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, Seoul, South Korea. 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.