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NCT Number: NCT07514637

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.

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.

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Experimental Group

Drug

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

Anrikefon

Drug

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

Primary outcomes

  1. The incidence of postoperative complications

    Time frame: After undergoing treatment for 2 months

  2. Incidence rate of adverse events

    Time frame: Two month after the treatment

  3. The VAS score within 0-72 hours after the operation

    Time frame: Within 3 days after receiving treatment

Secondary outcomes

  1. Changes in biochemical indicators and inflammatory indicators

    Time frame: One week after the treatment

    The unit of C-reactive protein is mg/L;The unit of WBC is ×109/L

  2. The time of first flatus and defecation after surgery, and the time to get out of bed for activities

    Time frame: One week after the treatment

    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.

  3. Postoperative hospital stay and hospitalization costs

    Time frame: After undergoing treatment for 2 months

    The postoperative hospital stay is calculated in days, and the hospitalization expenses are settled in RMB.

  4. Postoperative analgesia satisfaction scores of the subjects and the satisfaction scores of the study doctors after the administration of the medication were obtained.

    Time frame: Within 3 days after receiving treatment

    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.

  5. The initial pressing time of the postoperative analgesic pump, the total number of presses, and the number of effective presses

    Time frame: One day after the treatment

    The number of presses of the postoperative analgesic pump should be recorded based on the actual situation. Each press is counted as 1.

  6. The time for discontinuing postoperative analgesics

    Time frame: After undergoing treatment for 2 months

  7. The proportion and duration of VAS scores ≤ 3 points within 0-12 hours and 0-24 hours after the first postoperative administration

    Time frame: Within one day after receiving treatment

  8. The timing and dosage of remedial analgesia

    Time frame: After undergoing treatment for 2 months

Study contacts

Contact information is provided by the study sponsor or research team.

yudong QIU

CONTACT

[email protected]

0086+13809021967

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 7, 2026
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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