Comparing intrathecal morphine and continuous wound infiltration for pain relief after pancreatic surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial is a prospective randomized open-label noninferiority comparison of intrathecal morphine injection versus continuous wound infiltration for pain management following open pancreaticoduodenectomy. The study aims to evaluate the effectiveness of these two analgesic methods, particularly focusing on their ability to manage severe postoperative pain resulting from the surgical procedure. Intrathecal morphine is hypothesized to provide potent, long-lasting pain relief with a single injection, while continuous wound infiltration requires catheter placement and may not effectively address visceral pain. The trial will enroll adults scheduled for elective pancreatic surgery and assess their pain management outcomes postoperatively.

Why it matters

Who can join: the full rules

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

Where it's running

• Seoul National University Hospital
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Ho-jin Lee, M.D., PhD.
• Email: hjpainfree@snu.ac.kr
• Phone: +82-2-2072-0039

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.