Status:
ACTIVE_NOT_RECRUITING
Preperitoneal Analgesia Versus Epidural Analgesia After Open Pancreaticoduodenectomy
Lead Sponsor:
Seoul National University Hospital
Conditions:
Pain Management
Pain, Postoperative
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a prospective randomized open-label noninferiority trial that compares thoracic epidural analgesia and continuous preperitoneal analgesia after open pancreaticoduodenectomy.
Detailed Description
In the Enhanced recovery after surgery (ERAS) program of pancreaticoduodenectomy (PD), thoracic epidural analgesia (or epidural analgesia) was considered to be a key analgesic method because it not on...
Eligibility Criteria
Inclusion
- 18 years and older
- Disease of periampullary lesions
- Elective open pancreaticoduodenectomy (PD): PD or pylorus preserving pancreaticoduodenectomy (PPPD)
- Midline incision
- Written informed consent : ability to understand and the willingness to sign a written informed consent
- Performance status (ECOG scale): 0-1 at the time of enrollment
- Physical status (ASA) : 1-2 grade
Exclusion
- History of any abdominal surgery (except laparoscopic appendectomy, laparoscopic/robotic cholecystectomy, laparoscopic/robotic obstetrics and gynecology surgeries,Cesarean section, laparoscopic/robotic prostate surgery)
- Emergency operation
- History of chronic pain
- Chronic use of opioid, analgesics, anti-depressant, anti-epileptics (\>1year)
- Alcoholics
- Impossible to control PCA d/t delirium, cognitive impairment
- Contraindication for epidural analgesia
- Patients with coagulopathy (INR\>1.5, Prothrombin time\>1.5, platelets \<80x10\^9perL) or anti-coagulants
- Hypersensitive to fentanyl and ropivacaine
- Need other organ resection (ex. Liver, colon)
- Intubation
Key Trial Info
Start Date :
November 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT04375826
Start Date
November 13 2020
End Date
December 31 2024
Last Update
October 15 2024
Active Locations (1)
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1
Department of Surgery, Seoul National University College of Medicine
Seoul, South Korea, 110-744