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
Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This is a prospective randomized open-label noninferiority trial that compares intrathecal morphine injection and continuous wound infiltration after open pancreaticoduodenectomy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Republic of Korea
Seoul National University Hospital
RECRUITING
Seoul
Contact Information
Primary
Ho-jin Lee, M.D., PhD.
hjpainfree@snu.ac.kr
+82-2-2072-0039
Time Frame
Start Date: 2025-01-15
Estimated Completion Date: 2027-01-07
Participants
Target number of participants: 104
Treatments
Experimental: Intrathecal morphine injection
A single dose of intrathecal morphine is administered prior to induction of general anesthesia. Other postoperative pain management follows the institution's protocol including intravenous patient controlled analgesia.
Active_comparator: Continuous wound infiltration
A catheter is inserted at preperitoneal space at the end of surgery and ropivacaine is continuously infused until postoperative day 3. Other postoperative pain management follows the institution's protocol including intravenous patient controlled analgesia.
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital