Comparing intrathecal morphine and continuous wound infiltration for pain relief after pancreatic surgery
Effect of Single-Shot Intrathecal Morphine Injection Versus Continuous Wound Infiltration on Postoperative Pain After Pancreaticoduodenectomy: a Prospective, Open-Label, Randomized Controlled, Non-Inferiority Trial
This study is testing whether a single injection of morphine into the spine can help manage pain better than a continuous pain relief method after pancreatic surgery for adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul, Seoul) |
| Trial ID | NCT06761989 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older scheduled for elective open pancreaticoduodenectomy with a performance status of 0 or 1.
Not a fit: Patients with hypersensitivity to pain control medications or those with cognitive impairments affecting their ability to use pain management devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective and convenient pain management option for patients undergoing pancreatic surgery.
How similar studies have performed: Previous studies have shown that intrathecal morphine can provide effective analgesia, but this specific comparison with continuous wound infiltration has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Seoul, Seoul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.