RecruitingPhase 2NCT07514637

Safety and Efficacy of Anricfen for Postoperative Analgesia and Rehabilitation Promotion After Pancreaticoduodenectomy.Intervention Measures: For Normal Adults, Administer Ariceptin Injection Intravenously Post-operation at a Dose of 1 μg/Kgevery 8 Hours for Three Consecutive Days After Surgery.

The Safety and Efficacy of Aniracetamfen for Postoperative Analgesia and Rehabilitation After Pancreaticoduodenectomy: A Single-center, Single-arm Clinical Study


Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Enrollment

35 participants

Start Date

Nov 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria4

  • 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

Exclusion Criteria8

  • 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
  • History of allergy to NSAIDs, opioids, or to the test medication
  • Drug users, alcoholics, and opiate abusers
  • Those who had a history of chronic pain before the operation and a history of long-term use of analgesics and/or sedatives
  • Those who had thyroid dysfunction before the operation

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Interventions

DRUGExperimental Group

Postoperatively, administer Anrikefon injection intravenously at a dose of 1 μg/kg every 8 hours for three consecutive days.

DRUGAnrikefon

Postoperatively, intravenous injection of Anrikefon injection was administered at a dose of 1 μg/kg, every 8 hours, for three consecutive days as an intervention


Locations(1)

NanJing drum tower hospital

Nanjing, China

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NCT07514637