About this trial
Exploring the effectiveness and safety of early use of Ariceptinfen after pancreaticoduodenectomy in alleviating postoperative pain and promoting recovery of patients.
Main objective: To explore the analgesic effect of Anricfen after pancreaticoduodenectomy.
Secondary objective: To explore the impact of Anricfen on the accelerated recovery after pancreaticoduodenectomy.
Exploratory objective: To investigate the biomarkers of Anricfen's analgesic effect after pancreaticoduodenectomy, as well as its correlation factors with tumor pathology.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients who underwent pancreatic surgery, including pancreaticoduodenectomy (PD), pancreatic-preserving pancreaticoduodenectomy (PPPD), and laparoscopic pancreaticoduodenectomy (LPD)
Age ≥ 18 years old and < 80 years old
ASA Ⅰ-Ⅲ
Be able to clearly understand and voluntarily participate in the research
Disqualifiers
Merging severe primary diseases involving the heart, brain, liver, kidneys and hematopoietic system
History of long-term use of psychotropic drugs and cognitive dysfunction
Having a history of acute poisoning from alcohol, sleeping pills, painkillers or other drugs that affect the central nervous system
Pregnancy or lactation period
Trial design
Single group
Treatments tested in this trial
Experimental Group
DrugPostoperatively, administer Anrikefon injection intravenously at a dose of 1 μg/kg every 8 hours for three consecutive days.
Anrikefon
DrugPostoperatively, intravenous injection of Anrikefon injection was administered at a dose of 1 μg/kg, every 8 hours, for three consecutive days as an intervention
Treatment groups
Trial outcomes
Primary outcomes
The incidence of postoperative complications
Incidence rate of adverse events
The VAS score within 0-72 hours after the operation
Secondary outcomes
Changes in biochemical indicators and inflammatory indicators
The unit of C-reactive protein is mg/L;The unit of WBC is ×109/L
The time of first flatus and defecation after surgery, and the time to get out of bed for activities
The time of the first postoperative standing up for activities, passing gas, and having a bowel movement is calculated in days. The postoperative hospital stay is also calculated.
Postoperative hospital stay and hospitalization costs
The postoperative hospital stay is calculated in days, and the hospitalization expenses are settled in RMB.
Postoperative analgesia satisfaction scores of the subjects and the satisfaction scores of the study doctors after the administration of the medication were obtained.
The postoperative pain relief satisfaction score and the doctor satisfaction score are calculated on a scale of 0 to 10, with 10 being the highest score.
Sponsors and contacts
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