Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
NCT06761989

Intrathecal Morphine Injection Versus Continuous Wound Infiltration After Pancreaticoduodenectomy

Led by Seoul National University Hospital · Updated on 2025-03-19

104

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a prospective randomized open-label noninferiority trial that compares intrathecal morphine injection and continuous wound infiltration after open pancreaticoduodenectomy.

CONDITIONS

Official Title

Intrathecal Morphine Injection Versus Continuous Wound Infiltration After Pancreaticoduodenectomy

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 19 years of age or older
  • Scheduled for elective open pancreaticoduodenectomy or pylorus preserving pancreaticoduodenectomy
  • Diagnosis of periampullary lesions
  • Performance status with ECOG score of 0 or 1 at enrollment
  • Able to provide written informed consent, understand study procedures, and complete questionnaires
  • American Society of Anesthesiologists physical status I to III
Not Eligible

You will not qualify if you...

  • Allergy or hypersensitivity to fentanyl, ropivacaine, morphine, acetaminophen, or NSAIDs
  • Cognitive impairment affecting use of patient-controlled analgesia or questionnaires
  • Infection or abnormal anatomy of the abdominal wall or skin preventing catheter placement
  • Contraindications to intrathecal injection such as coagulation disorders or ongoing anticoagulant use
  • Major medical or psychiatric illness affecting treatment response
  • History of chronic pain or chronic use of analgesics or psychiatric medications
  • Severe liver or kidney disease
  • Any other condition deemed inappropriate for study participation by investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Seoul National University Hospital

Seoul, Seoul, South Korea, KS013

Actively Recruiting

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Research Team

H

Ho-jin Lee, M.D., PhD.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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